Trial Outcomes & Findings for Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF (NCT NCT04198701)

NCT ID: NCT04198701

Last Updated: 2025-02-13

Results Overview

Primary safety events are: Within 6 months post-ablation: * Pulmonary vein stenosis (≥70% diameter reduction) * Phrenic nerve injury/diaphragmatic paralysis (ongoing at 6 months) * Atrioesophageal fistula Within 30 days of ablation procedure: * Cardiac tamponade/perforation * Cerebrovascular accident * Major bleeding requiring transfusion * Myocardial infarction * Pericarditis requiring intervention * Transient ischemic attack * Vagal nerve injury resulting in esophageal dysmotility or gastroparesis * Vascular access complications requiring intervention * Systemic/pulmonary embolism requiring intervention * Pulmonary edema * Death * Any PulseSelect PFA System-related or PFA procedure-related cardiovascular and/or pulmonary adverse event that prolongs or requires hospitalization for more than 48 hours (excluding recurrent AF/AFL/AT)

Recruitment status

COMPLETED

Study phase

Target enrollment

421 participants

Primary outcome timeframe

up to 6 months

Results posted on

2025-02-13

Participant Flow

Participant milestones

Participant milestones
Measure	Pilot Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.	Pivotal - Roll-In Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.	Pivotal - Paroxysmal AF Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.	Pivotal - Persistent AF Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.
Overall Study STARTED	38	60	164	159
Overall Study Had Ablation Procedure	38	60	150	150
Overall Study COMPLETED	35	57	146	141
Overall Study NOT COMPLETED	3	3	18	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pilot n=38 Participants Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.	Pivotal - Roll-In n=60 Participants Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.	Pivotal - Paroxysmal AF n=164 Participants Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.	Pivotal - Persistent AF n=159 Participants Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.	Total n=421 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
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	25 Participants n=7 Participants	82 Participants n=5 Participants	66 Participants n=4 Participants	193 Participants n=21 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	35 Participants n=7 Participants	82 Participants n=5 Participants	93 Participants n=4 Participants	228 Participants n=21 Participants
Age, Continuous	62.2 years STANDARD_DEVIATION 11.3 • n=5 Participants	66.7 years STANDARD_DEVIATION 8.7 • n=7 Participants	63.1 years STANDARD_DEVIATION 10.4 • n=5 Participants	65.9 years STANDARD_DEVIATION 8.9 • n=4 Participants	64.6 years STANDARD_DEVIATION 9.8 • n=21 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	15 Participants n=7 Participants	61 Participants n=5 Participants	38 Participants n=4 Participants	132 Participants n=21 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	45 Participants n=7 Participants	103 Participants n=5 Participants	121 Participants n=4 Participants	289 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	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
Race (NIH/OMB) Asian	1 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants	16 Participants n=4 Participants	47 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	45 Participants n=7 Participants	121 Participants n=5 Participants	128 Participants n=4 Participants	328 Participants n=21 Participants
Race (NIH/OMB) More than one race	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
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants	14 Participants n=4 Participants	42 Participants n=21 Participants
Region of Enrollment Canada	8 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants	5 participants n=4 Participants	25 participants n=21 Participants
Region of Enrollment Austria	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	6 participants n=4 Participants	7 participants n=21 Participants
Region of Enrollment Netherlands	4 participants n=5 Participants	0 participants n=7 Participants	7 participants n=5 Participants	0 participants n=4 Participants	11 participants n=21 Participants
Region of Enrollment Belgium	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants	5 participants n=21 Participants
Region of Enrollment United States	21 participants n=5 Participants	43 participants n=7 Participants	126 participants n=5 Participants	121 participants n=4 Participants	311 participants n=21 Participants
Region of Enrollment Japan	0 participants n=5 Participants	8 participants n=7 Participants	20 participants n=5 Participants	16 participants n=4 Participants	44 participants n=21 Participants
Region of Enrollment Australia	5 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants	2 participants n=4 Participants	10 participants n=21 Participants
Region of Enrollment France	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants	3 participants n=21 Participants
Region of Enrollment Spain	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	4 participants n=4 Participants	5 participants n=21 Participants

PRIMARY outcome

Timeframe: up to 6 months

Population: Non roll-in pivotal patients that had a Pulsed Field Ablation procedure.

Outcome measures

Outcome measures
Measure	Pivotal - Paroxysmal AF n=150 Participants Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.	Pivotal - Persistent AF n=150 Participants Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.
Safety: Number of Participants With at Least One Primary Safety Event	1 Participants	1 Participants

PRIMARY outcome

Timeframe: up to 12 months

Population: Non roll-in pivotal patients that had a Pulsed Field Ablation procedure.

Treatment success is defined as freedom from treatment failure. The study requires 24-hour Holter monitoring at 6 and 12 months in addition to weekly and symptomatic patient activated ambulatory monitoring transmissions through 12 months, and 12-lead ECGs at all follow up visits. Treatment failure is defined as any of the following components: * Acute procedural failure * Documented AF/AT/AFL on Holter/patient activated ambulatory monitoring/12-lead ECG after the 90-day post-ablation blanking period. * Any subsequent AF surgery or ablation in the left atrium, except for one repeat PVI ablation using PFA within the 90-day blanking period. * Direct current cardioversion for atrial tachyarrhythmia recurrences after the 90-day blanking period. * Class I or III antiarrhythmic drug (AAD) dose increase from the historic maximum ineffective dose (prior to the ablation procedure) or initiation of a new Class I or III AAD after the 90-day blanking period.

Outcome measures

Outcome measures
Measure	Pivotal - Paroxysmal AF n=150 Participants Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.	Pivotal - Persistent AF n=150 Participants Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.
Effectiveness: Number of Participants With Treatment Success.	100 Participants	83 Participants

SECONDARY outcome

Timeframe: Baseline to 12 months post-ablation

Population: All participants who completed the EQ-5D questionnaire at baseline and 12 months

Change in EQ-5D score (12-month score - baseline score). The Euroqol EQ-5D questionnaire (5L version) is a standardized instrument for measuring general health status. The Euroqol EQ-5D questionnaire (which consists of a 5-question survey and a visual analog scale) has a composite score based on the 5-question survey that ranges from 0 (least healthy) to 1 (most healthy).

Outcome measures

Outcome measures
Measure	Pivotal - Paroxysmal AF n=144 Participants Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.	Pivotal - Persistent AF n=140 Participants Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.
Quality of Life - Change in EQ-5D Score	0.05 units on a scale Interval 0.02 to 0.08	0.06 units on a scale Interval 0.04 to 0.09

SECONDARY outcome

Timeframe: Baseline to 12 months post-ablation

Population: All participants who completed the AFEQT questionnaire at baseline and 12 months

Change in AFEQT score (12-month score - baseline score). The AFEQT questionnaire is an atrial fibrillation (AF) specific health-related quality of life questionnaire to assess the impact of AF on a subject's life. The overall score ranges from 0 - 100, with 0 corresponding to complete disability and 100 corresponding to no disability

Outcome measures

Outcome measures
Measure	Pivotal - Paroxysmal AF n=144 Participants Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.	Pivotal - Persistent AF n=140 Participants Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.
Quality of Life - Change in AFEQT Score	29.4 units on a scale Interval 25.8 to 33.1	29.0 units on a scale Interval 25.5 to 32.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: Pilot patients

Serious adverse events that count toward the endpoint are: Pulmonary vein stenosis (\>70% diameter reduction) Atrioesophageal fistula Cardiac tamponade/perforation Cerebrovascular accident Major bleeding requiring transfusion Myocardial infarction Pericarditis requiring intervention Transient ischemic attack Vagal nerve injury resulting in esophageal dysmotility or gastroparesis Vascular access complications requiring intervention Systemic/pulmonary embolism requiring intervention Pulmonary edema Death

Outcome measures

Outcome measures
Measure	Pivotal - Paroxysmal AF n=38 Participants Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.	Pivotal - Persistent AF Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.
Pilot Phase Safety: Number of Participants With a PFA System-related and PFA Procedure-related Serious Adverse Event (SAE) Within 30 Days Post-ablation.	0 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Acute (day of procedure)

Population: Pilot patients

Acute procedural failure is defined as the occurrence of any of the following: 1. Inability to isolate all accessible targeted pulmonary veins (assessed for entrance block and, where assessable, exit block) during the index ablation procedure. 2. Ablation using a non-study device in the left atrium. Acute procedural success is the opposite of acute procedural failure.

Outcome measures

Outcome measures
Measure	Pivotal - Paroxysmal AF n=38 Participants Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.	Pivotal - Persistent AF Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.
Pilot Phase Effectiveness: Number of Participants With Acute Procedural Success of PVI Ablation With the PFA System.	38 Participants	—

Adverse Events

Pilot

Serious events: 13 serious events

Other events: 19 other events

Deaths: 1 deaths

Pivotal - Roll-In

Serious events: 20 serious events

Other events: 17 other events

Deaths: 1 deaths

Pivotal - Paroxysmal AF

Serious events: 38 serious events

Other events: 39 other events

Deaths: 1 deaths

Pivotal - Persistent AF

Serious events: 56 serious events

Other events: 53 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Pilot n=38 participants at risk Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.	Pivotal - Roll-In n=60 participants at risk Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.	Pivotal - Paroxysmal AF n=164 participants at risk Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.	Pivotal - Persistent AF n=159 participants at risk Medtronic PulseSelect Pulsed Field Ablation (PFA) System: Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.
Cardiac disorders Atrial fibrillation	18.4% 7/38 • Number of events 15 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	13.3% 8/60 • Number of events 10 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	10.4% 17/164 • Number of events 20 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	18.9% 30/159 • Number of events 37 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment
Cardiac disorders Atrial flutter	7.9% 3/38 • Number of events 4 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	5.0% 3/60 • Number of events 3 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	5.5% 9/164 • Number of events 12 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	6.9% 11/159 • Number of events 13 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment
Cardiac disorders Atrial tachycardia	5.3% 2/38 • Number of events 2 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	1.7% 1/60 • Number of events 1 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.61% 1/164 • Number of events 1 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.63% 1/159 • Number of events 1 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment
Eye disorders Palpitations	13.2% 5/38 • Number of events 6 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.00% 0/60 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	1.8% 3/164 • Number of events 3 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.63% 1/159 • Number of events 1 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment
Cardiac disorders Supraventricular extrasystoles	5.3% 2/38 • Number of events 2 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.00% 0/60 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.61% 1/164 • Number of events 1 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	2.5% 4/159 • Number of events 4 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment
Cardiac disorders Ventricular extrasystoles	5.3% 2/38 • Number of events 2 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	1.7% 1/60 • Number of events 1 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.61% 1/164 • Number of events 1 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.63% 1/159 • Number of events 1 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment
General disorders Chest pain	5.3% 2/38 • Number of events 2 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	3.3% 2/60 • Number of events 2 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	1.2% 2/164 • Number of events 2 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.00% 0/159 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment
General disorders Fatigue	5.3% 2/38 • Number of events 2 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.00% 0/60 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	1.2% 2/164 • Number of events 2 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.00% 0/159 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment
Injury, poisoning and procedural complications Procedural pain	10.5% 4/38 • Number of events 4 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.00% 0/60 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.00% 0/164 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.63% 1/159 • Number of events 1 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment
Injury, poisoning and procedural complications Vascular access site haematoma	7.9% 3/38 • Number of events 3 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.00% 0/60 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.61% 1/164 • Number of events 1 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.63% 1/159 • Number of events 1 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment
Injury, poisoning and procedural complications Vascular access site haemorrhage	5.3% 2/38 • Number of events 2 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.00% 0/60 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.00% 0/164 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	1.9% 3/159 • Number of events 3 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	5.3% 2/38 • Number of events 2 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	1.7% 1/60 • Number of events 1 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.61% 1/164 • Number of events 1 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.00% 0/159 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment
Nervous system disorders Dizziness	0.00% 0/38 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	5.0% 3/60 • Number of events 3 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	1.2% 2/164 • Number of events 2 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	0.63% 1/159 • Number of events 1 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/38 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	3.3% 2/60 • Number of events 2 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	6.7% 11/164 • Number of events 11 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment	6.3% 10/159 • Number of events 10 • Study enrollment to 12 months post-ablation All adverse events were collected. Serious adverse event: Adverse event that 1. led to death, 2. led to serious deterioration in the health as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure, including chronic disease, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment

Additional Information

Clinical Research Specialist

Medtronic, Inc.

Phone: 800-328-2518

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60