Trial Outcomes & Findings for INhalation of Flecainide to Convert Recent Onset SympTomatic Atrial Fibrillation to siNus rhyThm (INSTANT) (NCT NCT03539302)

Last Updated: 2024-05-14

Results Overview

To evaluate the conversion of AF to SR and symptom relief by inhaled flecainide acetate inhalation solution, under two oral inhalation dosing regimens in subjects with recent onset of paroxysmal AF. The subjects will be monitored via ECG and telemetry while in the hospital for 90 minutes.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

176 participants

Primary outcome timeframe

90 minutes

Results posted on

2024-05-14

Participant Flow

Participant milestones

Participant milestones
Measure	Part A - 30 mg Dose Group Part A single administration of 30 mg flecainide acetate oral inhalation solution (FlecIH-102) for acute conversion of recent onset of paroxysmal AF to SR	Part A- 60 mg Dose Group Part A repeat dose administration of 60 mg flecainide acetate oral inhalation solution (FlecIH-102) for acute conversion of recent onset of paroxysmal AF to SR	Part A- 90 mg Dose Group Part A repeat administration of 90 mg flecainide acetate oral inhalation solution (FlecIH-102) for acute conversion of recent onset of paroxysmal AF to SR	Part A- 120 mg Dose Group Using FlecIH-102 Part A repeat administration of 120 mg flecainide acetate oral inhalation solution (FlecIH-102) for acute conversion of recent onset of paroxysmal AF to SR	Part A- 120 mg Dose Group Using FlecIH-103 Part A repeat administration of 120 mg flecainide acetate oral inhalation solution (FlecIH-103) for acute conversion of recent onset of paroxysmal AF to SR	Part B- Dose Confirmation Using 120 mg of FlecIH-103 Part B was designed to confirm the safety and efficacy of the optimal dose and inhalation solution selected in Part A. Patients received 120 mg of FlecIH-103 for acute cardioversion of AF to SR.	Part C- Cohort Expansion With Exploratory Evaluation of Hand Held Echo Part C was designed to expand the cohort for medically-led administration of 120 mg of flecainide acetate inhalation solution (FlecIH-103) and to explore the feasibility of patient-led self-administration of flecainide acetate inhalation solution in a hospital setting under medical supervision. The feasibility of implementing a portable cardiac ultrasound (handheld echocardiogram \[HHE\]) was assessed at screening.
Overall Study STARTED	10	22	21	19	29	26	45
Overall Study COMPLETED	10	22	21	19	29	25	44
Overall Study NOT COMPLETED	0	0	0	0	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A - 30 mg Dose Group Part A single administration of 30 mg flecainide acetate oral inhalation solution (FlecIH-102) for acute conversion of recent onset of paroxysmal AF to SR	Part A- 60 mg Dose Group Part A repeat dose administration of 60 mg flecainide acetate oral inhalation solution (FlecIH-102) for acute conversion of recent onset of paroxysmal AF to SR	Part A- 90 mg Dose Group Part A repeat administration of 90 mg flecainide acetate oral inhalation solution (FlecIH-102) for acute conversion of recent onset of paroxysmal AF to SR	Part A- 120 mg Dose Group Using FlecIH-102 Part A repeat administration of 120 mg flecainide acetate oral inhalation solution (FlecIH-102) for acute conversion of recent onset of paroxysmal AF to SR	Part A- 120 mg Dose Group Using FlecIH-103 Part A repeat administration of 120 mg flecainide acetate oral inhalation solution (FlecIH-103) for acute conversion of recent onset of paroxysmal AF to SR	Part B- Dose Confirmation Using 120 mg of FlecIH-103 Part B was designed to confirm the safety and efficacy of the optimal dose and inhalation solution selected in Part A. Patients received 120 mg of FlecIH-103 for acute cardioversion of AF to SR.	Part C- Cohort Expansion With Exploratory Evaluation of Hand Held Echo Part C was designed to expand the cohort for medically-led administration of 120 mg of flecainide acetate inhalation solution (FlecIH-103) and to explore the feasibility of patient-led self-administration of flecainide acetate inhalation solution in a hospital setting under medical supervision. The feasibility of implementing a portable cardiac ultrasound (handheld echocardiogram \[HHE\]) was assessed at screening.
Overall Study Spontaneous cardio version	0	0	0	0	0	1	1

Baseline Characteristics

INhalation of Flecainide to Convert Recent Onset SympTomatic Atrial Fibrillation to siNus rhyThm (INSTANT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A- Dose Escalation 30 mg FlecIH-102 n=10 Participants To evaluate the feasibility of single administration of 30 mg flecainide acetate oral inhalation solution, FlecIH-102 for acute conversion of recent onset of paroxysmal AF to SR.	Part A- Dose Escalation 60 mg FlecIH-102 n=22 Participants To evaluate the feasibility of repeat administration of 60 mg flecainide acetate oral inhalation solution, FlecIH-102 for acute conversion of recent onset of paroxysmal AF to SR.	Part A- Dose Escalation 90 mg FlecIH-102 n=21 Participants To evaluate the feasibility of repeat administration of 90 mg flecainide acetate oral inhalation solution, FlecIH-102 for acute conversion of recent onset of paroxysmal AF to SR.	Part A- Dose Escalation 120 mg FlecIH-102 n=19 Participants To evaluate the feasibility of repeat administration of 120 mg flecainide acetate oral inhalation solution, FlecIH-102 for acute conversion of recent onset of paroxysmal AF to SR.	Part A- Dose Escalation 120 mg FlecIH-103 n=29 Participants To evaluate the feasibility of repeat administration of 120 mg flecainide acetate oral inhalation solution, FlecIH-103 for acute conversion of recent onset of paroxysmal AF to SR.	Part B- Dose Confirmation n=25 Participants Part B was designed to confirm the safety and efficacy of the optimal dose (120 mg) selected in Part A using FlecIH-103.	Part C- Cohort Expansion With Exploratory Evaluation of a Hand Held Echo Device n=44 Participants Part C was designed to expand the cohort for medically-led administration of flecainide acetate inhalation solution and to explore the feasibility of patient-led self-administration of flecainide acetate inhalation solution in a hospital setting under medical supervision. Part C also included the evaluation of handheld echo device used at bedside to assess feasibility of its use during screening in an emergent setting.	Total n=170 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants	13 Participants n=4 Participants	17 Participants n=21 Participants	13 Participants n=10 Participants	29 Participants n=115 Participants	108 Participants n=24 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	10 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	12 Participants n=21 Participants	12 Participants n=10 Participants	15 Participants n=115 Participants	62 Participants n=24 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	11 Participants n=4 Participants	10 Participants n=21 Participants	8 Participants n=10 Participants	16 Participants n=115 Participants	58 Participants n=24 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	17 Participants n=7 Participants	14 Participants n=5 Participants	8 Participants n=4 Participants	19 Participants n=21 Participants	17 Participants n=10 Participants	28 Participants n=115 Participants	112 Participants n=24 Participants
Race/Ethnicity, Customized White	8 Participants n=5 Participants	21 Participants n=7 Participants	18 Participants n=5 Participants	18 Participants n=4 Participants	26 Participants n=21 Participants	24 Participants n=10 Participants	42 Participants n=115 Participants	157 Participants n=24 Participants
Race/Ethnicity, Customized Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	9 Participants n=24 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	3 Participants n=24 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=24 Participants
Body Mass Index (BMI)	27 Kg/m2 STANDARD_DEVIATION 3.9 • n=5 Participants	26 Kg/m2 STANDARD_DEVIATION 3.06 • n=7 Participants	27 Kg/m2 STANDARD_DEVIATION 3.86 • n=5 Participants	28 Kg/m2 STANDARD_DEVIATION 5.4 • n=4 Participants	26 Kg/m2 STANDARD_DEVIATION 3.7 • n=21 Participants	27 Kg/m2 STANDARD_DEVIATION 3.85 • n=10 Participants	27 Kg/m2 STANDARD_DEVIATION 4.07 • n=115 Participants	27 Kg/m2 STANDARD_DEVIATION 3.97 • n=24 Participants

PRIMARY outcome

Timeframe: 90 minutes

Population: Modified Intent to Treat (mITT)

Outcome measures

Outcome measures
Measure	Part A- Dose Escalation (30 mg) n=10 Participants Part A was designed to evaluate the feasibility of single and repeat administration of escalating doses of flecainide acetate oral inhalation solutions for acute conversion of recent onset of paroxysmal AF to SR.	Part A- Dose Escalation (60 mg) n=20 Participants Part A was designed to evaluate the feasibility of single and repeat administration of escalating doses of flecainide acetate oral inhalation solutions for acute conversion of recent onset of paroxysmal AF to SR.	Part A- Dose Escalation (90 mg) n=21 Participants Part A was designed to evaluate the feasibility of single and repeat administration of escalating doses of flecainide acetate oral inhalation solutions for acute conversion of recent onset of paroxysmal AF to SR.	Part A- Dose Escalation (120 mg) FlecIH-102 n=17 Participants Part A was designed to evaluate the feasibility of single and repeat administration of escalating doses of flecainide acetate oral inhalation solutions for acute conversion of recent onset of paroxysmal AF to SR.	Part A- Dose Escalation (120 mg) FlecIH-103 n=27 Participants Part A was designed to evaluate the feasibility of single and repeat administration of escalating doses of flecainide acetate oral inhalation solutions for acute conversion of recent onset of paroxysmal AF to SR.	Part B- Dose Confirmation n=24 Participants Part B was designed to confirm the safety and efficacy of the optimal dose selected in Part A	Part C- Cohort Expansion With Exploratory Evaluation of Handheld Echo n=43 Participants Part C was designed to expand the cohort for medically-led administration of flecainide acetate inhalation solution and to explore the feasibility of patient-led self-administration of flecainide acetate inhalation solution in a hospital setting under medical supervision. The feasibility of the use a handheld echo device was assessed during screening in an emergent setting.
Percentage of Participants With Successful Conversion of Atrial Fibrillation to Sinus Rhythm	10 percentage of participants	35 percentage of participants	33 percentage of participants	41 percentage of participants	48 percentage of participants	50 percentage of participants	35 percentage of participants

SECONDARY outcome

Timeframe: 90 minutes

Population: PK Population

To explore the population pharmacokinetics (PK) of inhaled flecainide under two oral inhalation dosing regimens in subjects with recent onset paroxysmal AF. Blood samples are collected from each subject for pharmacokinetic analysis.

Outcome measures

Outcome measures
Measure	Part A- Dose Escalation (30 mg) n=10 Participants Part A was designed to evaluate the feasibility of single and repeat administration of escalating doses of flecainide acetate oral inhalation solutions for acute conversion of recent onset of paroxysmal AF to SR.	Part A- Dose Escalation (60 mg) n=22 Participants Part A was designed to evaluate the feasibility of single and repeat administration of escalating doses of flecainide acetate oral inhalation solutions for acute conversion of recent onset of paroxysmal AF to SR.	Part A- Dose Escalation (90 mg) n=21 Participants Part A was designed to evaluate the feasibility of single and repeat administration of escalating doses of flecainide acetate oral inhalation solutions for acute conversion of recent onset of paroxysmal AF to SR.	Part A- Dose Escalation (120 mg) FlecIH-102 n=19 Participants Part A was designed to evaluate the feasibility of single and repeat administration of escalating doses of flecainide acetate oral inhalation solutions for acute conversion of recent onset of paroxysmal AF to SR.	Part A- Dose Escalation (120 mg) FlecIH-103 n=29 Participants Part A was designed to evaluate the feasibility of single and repeat administration of escalating doses of flecainide acetate oral inhalation solutions for acute conversion of recent onset of paroxysmal AF to SR.	Part B- Dose Confirmation n=25 Participants Part B was designed to confirm the safety and efficacy of the optimal dose selected in Part A	Part C- Cohort Expansion With Exploratory Evaluation of Handheld Echo n=44 Participants Part C was designed to expand the cohort for medically-led administration of flecainide acetate inhalation solution and to explore the feasibility of patient-led self-administration of flecainide acetate inhalation solution in a hospital setting under medical supervision. The feasibility of the use a handheld echo device was assessed during screening in an emergent setting.
PK Objectives by Analyzing Blood Samples to Evaluate Peak Plasma Concentration (Cmax)	127 ng/mL Standard Deviation 99.5	213 ng/mL Standard Deviation 217.3	262 ng/mL Standard Deviation 28.7	408 ng/mL Standard Deviation 263	387 ng/mL Standard Deviation 209.1	323.4 ng/mL Standard Deviation 217.8	381.5 ng/mL Standard Deviation 236.6

SECONDARY outcome

Timeframe: 90 minutes

Population: Safety Population

To explore the electrocardiographic effects of inhaled flecainide under two oral inhalation dosing regimens in subjects with recent onset of paroxysmal AF. Serial 12-Lead ECG measurements are extracted from the Holter recording in triplicate before, after the allocated inhalation regimen and at the time of conversion to sinus rhythm for pharmacodynamic analysis.

Outcome measures

Outcome measures
Measure	Part A- Dose Escalation (30 mg) n=10 Participants Part A was designed to evaluate the feasibility of single and repeat administration of escalating doses of flecainide acetate oral inhalation solutions for acute conversion of recent onset of paroxysmal AF to SR.	Part A- Dose Escalation (60 mg) n=22 Participants Part A was designed to evaluate the feasibility of single and repeat administration of escalating doses of flecainide acetate oral inhalation solutions for acute conversion of recent onset of paroxysmal AF to SR.	Part A- Dose Escalation (90 mg) n=21 Participants Part A was designed to evaluate the feasibility of single and repeat administration of escalating doses of flecainide acetate oral inhalation solutions for acute conversion of recent onset of paroxysmal AF to SR.	Part A- Dose Escalation (120 mg) FlecIH-102 n=19 Participants Part A was designed to evaluate the feasibility of single and repeat administration of escalating doses of flecainide acetate oral inhalation solutions for acute conversion of recent onset of paroxysmal AF to SR.	Part A- Dose Escalation (120 mg) FlecIH-103 n=29 Participants Part A was designed to evaluate the feasibility of single and repeat administration of escalating doses of flecainide acetate oral inhalation solutions for acute conversion of recent onset of paroxysmal AF to SR.	Part B- Dose Confirmation n=25 Participants Part B was designed to confirm the safety and efficacy of the optimal dose selected in Part A	Part C- Cohort Expansion With Exploratory Evaluation of Handheld Echo n=44 Participants Part C was designed to expand the cohort for medically-led administration of flecainide acetate inhalation solution and to explore the feasibility of patient-led self-administration of flecainide acetate inhalation solution in a hospital setting under medical supervision. The feasibility of the use a handheld echo device was assessed during screening in an emergent setting.
Pharmacodynamics (PD) Objectives by Performing Serial 12-Lead ECG Recordings (Changes in QRS)	4.3 msec Standard Deviation 13.6	2.6 msec Standard Deviation 4.9	2.9 msec Standard Deviation 3.1	7.9 msec Standard Deviation 8.1	6.6 msec Standard Deviation 4.2	7.0 msec Standard Deviation 9.3	4.5 msec Standard Deviation 4.3

Adverse Events

Part A 30 mg Dose Using FlecIH-102

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Part A 60 mg Dose Using FlecIH-102

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Part A 90 mg Dose Using FlecIH-102

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Part A 120 mg Dose Using FlecIH-102

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Part A 120 mg Dose Using FlecIH-103

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

Part B 120 mg Dose Using FlecIH-103

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Part C 120 mg Dose Using FlecIH-103

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A 30 mg Dose Using FlecIH-102 n=10 participants at risk 30 mg dose using FlecIH-102 for acute cardioversion of AF to SR	Part A 60 mg Dose Using FlecIH-102 n=22 participants at risk 60 mg dose using FlecIH-102 for acute cardioversion of AF to SR	Part A 90 mg Dose Using FlecIH-102 n=21 participants at risk 90 mg dose using FlecIH-102 for acute cardioversion of AF to SR	Part A 120 mg Dose Using FlecIH-102 n=19 participants at risk 120 mg dose using FlecIH-102 for acute cardioversion of AF to SR	Part A 120 mg Dose Using FlecIH-103 n=29 participants at risk 120 mg dose using FlecIH-103 for acute cardioversion of AF to SR	Part B 120 mg Dose Using FlecIH-103 n=25 participants at risk Dose confirmation cohort for 120 mg dose group using the final formulation of study drug, FlecIH-103.	Part C 120 mg Dose Using FlecIH-103 n=44 participants at risk Dose expansion cohort for 120 mg dose using the final formulation of study drug, FlecIH-103.
Cardiac disorders Bradycardia	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.8% 1/21 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	3.4% 1/29 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Cardiac disorders Atrial flutter with 1:1 AV conduction	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	3.4% 1/29 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Cardiac disorders Sinus node dysfuntion	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
General disorders Malaise	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Cardiac disorders Atrial fibrillation (hospitalization for recurrence of AF)	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Cardiac disorders Sinus arrest/Ventricular systole (asystolic pause)	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)

Other adverse events

Other adverse events
Measure	Part A 30 mg Dose Using FlecIH-102 n=10 participants at risk 30 mg dose using FlecIH-102 for acute cardioversion of AF to SR	Part A 60 mg Dose Using FlecIH-102 n=22 participants at risk 60 mg dose using FlecIH-102 for acute cardioversion of AF to SR	Part A 90 mg Dose Using FlecIH-102 n=21 participants at risk 90 mg dose using FlecIH-102 for acute cardioversion of AF to SR	Part A 120 mg Dose Using FlecIH-102 n=19 participants at risk 120 mg dose using FlecIH-102 for acute cardioversion of AF to SR	Part A 120 mg Dose Using FlecIH-103 n=29 participants at risk 120 mg dose using FlecIH-103 for acute cardioversion of AF to SR	Part B 120 mg Dose Using FlecIH-103 n=25 participants at risk Dose confirmation cohort for 120 mg dose group using the final formulation of study drug, FlecIH-103.	Part C 120 mg Dose Using FlecIH-103 n=44 participants at risk Dose expansion cohort for 120 mg dose using the final formulation of study drug, FlecIH-103.
General disorders Malaise	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
General disorders Non-cardiac chest pain	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	3.4% 1/29 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Cardiac disorders Atrial Flutter	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	13.8% 4/29 • Number of events 4 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	6.8% 3/44 • Number of events 3 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Respiratory, thoracic and mediastinal disorders Salivary Hypersecretion	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	19.0% 4/21 • Number of events 4 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	6.9% 2/29 • Number of events 2 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	8.0% 2/25 • Number of events 2 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	6.8% 3/44 • Number of events 3 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Respiratory, thoracic and mediastinal disorders Cough	80.0% 8/10 • Number of events 8 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	40.9% 9/22 • Number of events 9 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	52.4% 11/21 • Number of events 11 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	68.4% 13/19 • Number of events 13 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	41.4% 12/29 • Number of events 12 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	44.0% 11/25 • Number of events 11 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	34.1% 15/44 • Number of events 15 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.8% 1/21 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	15.8% 3/19 • Number of events 3 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	10.3% 3/29 • Number of events 3 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	16.0% 4/25 • Number of events 4 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	6.9% 2/29 • Number of events 2 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	13.6% 6/44 • Number of events 6 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	13.6% 3/22 • Number of events 3 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	19.0% 4/21 • Number of events 4 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	21.1% 4/19 • Number of events 4 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	13.8% 4/29 • Number of events 4 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	12.0% 3/25 • Number of events 3 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Cardiac disorders Bradycardia	10.0% 1/10 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.8% 1/21 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	6.9% 2/29 • Number of events 2 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	2.3% 1/44 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Cardiac disorders Atrial tachycardia	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.8% 1/21 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Cardiac disorders Cardiac flutter	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Cardiac disorders Palpitations	10.0% 1/10 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.8% 1/21 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	3.4% 1/29 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Eye disorders Lacrimation increased	10.0% 1/10 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
General disorders Chest pain	10.0% 1/10 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Investigations Oxygen saturation abnormal	10.0% 1/10 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Nervous system disorders Dizziness	20.0% 2/10 • Number of events 2 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	10.3% 3/29 • Number of events 3 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	2.3% 1/44 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Respiratory, thoracic and mediastinal disorders Hyperventilation	10.0% 1/10 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Respiratory, thoracic and mediastinal disorders Pharyngeal paraesthesia	10.0% 1/10 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 2/44 • Number of events 2 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Respiratory, thoracic and mediastinal disorders Pharyngeal swelling	10.0% 1/10 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	12.0% 3/25 • Number of events 3 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Respiratory, thoracic and mediastinal disorders Throat irritation	10.0% 1/10 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	27.3% 6/22 • Number of events 6 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.8% 1/21 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	15.8% 3/19 • Number of events 3 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	3.4% 1/29 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	8.0% 2/25 • Number of events 2 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 2/44 • Number of events 2 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Skin and subcutaneous tissue disorders Hyperhidrosis	10.0% 1/10 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.8% 1/21 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	2.3% 1/44 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Vascular disorders Blood pressure fluctuation	10.0% 1/10 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Vascular disorders Hypotension	10.0% 1/10 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.8% 1/21 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	10.5% 2/19 • Number of events 2 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	10.3% 3/29 • Number of events 3 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	2.3% 1/44 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Cardiac disorders Sinus node dysfunction	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Gastrointestinal disorders Dry mouth	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	9.1% 2/22 • Number of events 2 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	3.4% 1/29 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Gastrointestinal disorders Dysphagia	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	9.1% 2/22 • Number of events 2 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	14.3% 3/21 • Number of events 3 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	10.5% 2/19 • Number of events 2 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	6.9% 2/29 • Number of events 2 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 2/44 • Number of events 2 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
General disorders Condition aggravated	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	9.1% 2/22 • Number of events 2 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	14.3% 3/21 • Number of events 3 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	10.5% 2/19 • Number of events 2 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	6.9% 2/29 • Number of events 2 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
General disorders Fatigue	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.8% 1/21 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	3.4% 1/29 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	2.3% 1/44 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
General disorders Sensation of foreign body	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	2.3% 1/44 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Nervous system disorders Headache	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	3.4% 1/29 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	12.0% 3/25 • Number of events 3 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Psychiatric disorders Anxiety	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	2.3% 1/44 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Respiratory, thoracic and mediastinal disorders Throat tightness	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	3.4% 1/29 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 1/22 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Cardiac disorders Sinus arrest	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.8% 1/21 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Cardiac disorders SV extrasystoles	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.8% 1/21 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Cardiac disorders SV tachycardia	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.8% 1/21 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Gastrointestinal disorders Flatulence	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.8% 1/21 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Gastrointestinal disorders Odynophagia	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.8% 1/21 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	2.3% 1/44 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Cardiac disorders Sinus Bradycardia	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Cardiac disorders Ventricular Systole	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Gastrointestinal disorders Nausea	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	3.4% 1/29 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	2.3% 1/44 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Gastrointestinal disorders Vomiting	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
General disorders Chest Discomfort	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	6.9% 2/29 • Number of events 2 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Nervous system disorders Dysgeusia	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.5% 2/44 • Number of events 2 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Respiratory, thoracic and mediastinal disorders Dry Throat	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/21 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/44 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Respiratory, thoracic and mediastinal disorders Respiratory Tract Irritation	0.00% 0/10 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/22 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	4.8% 1/21 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/19 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/29 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	0.00% 0/25 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)	2.3% 1/44 • Number of events 1 • Adverse events were collected from the time of consent through Day 5. The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)

Additional Information

VP Clinical Operations

InCarda Therapeutics

Phone: 510-422-5522

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place