Trial Outcomes & Findings for FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF) (NCT NCT02703454)

Last Updated: 2019-05-21

Results Overview

Freedom from AF/AT recurrence is defined as no documented episodes of AF/AT \> 30 seconds with conventional non-invasive monitoring. In the case of a cardiac implanted electronic device (CIED), freedom from AF recurrence is defined as no documented episodes of AF/AT \> 30 seconds in a 72-hour window at the follow-up visits in addition to any symptomatic episodes with documented AF \> 30 seconds. AT recurrence does not include episodes of cavotricuspid isthmus (CTI) dependent flutter.

Recruitment status

TERMINATED

Study phase

Target enrollment

51 participants

Primary outcome timeframe

3 -12 months post study treatment.

Results posted on

2019-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	FIRM-only Subjects in this arm will be treated with Focal Impulse and Rotor Modulation (FIRM)-guided conventional radio frequency (RF) ablation without pulmonary vein isolation (PVI). FIRM-guided RF ablation	Conventional Subjects in this arm will undergo conventional RF ablation with confirmation of PVI. Conventional RF ablation
Overall Study STARTED	24	27
Overall Study Treated	23	24
Overall Study COMPLETED	13	11
Overall Study NOT COMPLETED	11	16

Reasons for withdrawal

Reasons for withdrawal
Measure	FIRM-only Subjects in this arm will be treated with Focal Impulse and Rotor Modulation (FIRM)-guided conventional radio frequency (RF) ablation without pulmonary vein isolation (PVI). FIRM-guided RF ablation	Conventional Subjects in this arm will undergo conventional RF ablation with confirmation of PVI. Conventional RF ablation
Overall Study Not treated	1	3
Overall Study Withdrawal by Subject	4	3
Overall Study Lost to Follow-up	1	2
Overall Study Study discontinuation	5	8

Baseline Characteristics

FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FIRM-only n=24 Participants Subjects in this arm will be treated with FIRM-guided conventional RF ablation without pulmonary vein isolation (PVI). FIRM-guided RF ablation	Conventional n=27 Participants Subjects in this arm will undergo conventional RF ablation with confirmation of PVI. Conventional RF ablation	Total n=51 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 11.4 • n=5 Participants	65 years STANDARD_DEVIATION 9.7 • n=7 Participants	63 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	25 Participants n=7 Participants	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Body Mass Index (BMI)	27 kg/m^2 STANDARD_DEVIATION 6.2 • n=5 Participants	28 kg/m^2 STANDARD_DEVIATION 5.5 • n=7 Participants	28 kg/m^2 STANDARD_DEVIATION 5.8 • n=5 Participants
European Heart Rhythm Association (EHRA) symptom classification in atrial fibrillation (AF) Class I	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
European Heart Rhythm Association (EHRA) symptom classification in atrial fibrillation (AF) Class II	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
European Heart Rhythm Association (EHRA) symptom classification in atrial fibrillation (AF) Class III	14 Participants n=5 Participants	18 Participants n=7 Participants	32 Participants n=5 Participants
European Heart Rhythm Association (EHRA) symptom classification in atrial fibrillation (AF) Class IV	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
European Heart Rhythm Association (EHRA) symptom classification in atrial fibrillation (AF) Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
History of Arterial Hypertension Yes	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
History of Arterial Hypertension No	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
History of Arterial Hypertension Unknown	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
History of Coronary Artery Disease Yes	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
History of Coronary Artery Disease No	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
History of Coronary Artery Disease Unknown	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
History of Chronic Renal Insufficiency Yes	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
History of Chronic Renal Insufficiency No	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
History of Chronic Renal Insufficiency Unknown	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Left Atrial Diameter	44 mm STANDARD_DEVIATION 5.5 • n=5 Participants	44 mm STANDARD_DEVIATION 7.3 • n=7 Participants	44 mm STANDARD_DEVIATION 6.4 • n=5 Participants
Anti-Arrhythmic Use at Baseline: Amiodarone Yes	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Anti-Arrhythmic Use at Baseline: Amiodarone No	22 Participants n=5 Participants	25 Participants n=7 Participants	47 Participants n=5 Participants
Anti-Arrhythmic Use at Baseline: Amiodarone Unknown	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Anti-Arrhythmic Use at Baseline: Dronedarone Yes	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Anti-Arrhythmic Use at Baseline: Dronedarone No	24 Participants n=5 Participants	25 Participants n=7 Participants	49 Participants n=5 Participants
Anti-Arrhythmic Use at Baseline: Dronedarone Unknown	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Anti-Arrhythmic Use at Baseline: Flecainide Yes	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Anti-Arrhythmic Use at Baseline: Flecainide No	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Anti-Arrhythmic Use at Baseline: Flecainide Unknown	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Anti-Arrhythmic Use at Baseline: Propafenone Yes	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Anti-Arrhythmic Use at Baseline: Propafenone No	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 Participants
Anti-Arrhythmic Use at Baseline: Propafenone Unknown	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Anti-Arrhythmic Use at Baseline: Sotalol Yes	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Anti-Arrhythmic Use at Baseline: Sotalol No	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Anti-Arrhythmic Use at Baseline: Sotalol Unknown	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 -12 months post study treatment.

Population: Patients with 12-month follow-up data

Outcome measures

Outcome measures
Measure	FIRM-only n=16 Participants Subjects in this arm will be treated with FIRM-guided conventional RF ablation without pulmonary vein isolation (PVI). FIRM-guided RF ablation	Conventional n=10 Participants Subjects in this arm will undergo conventional RF ablation with confirmation of PVI. Conventional RF ablation
Number of Participants With Single-procedure Freedom From AF/AT Recurrence From 3-12 Months Post Index Ablation Procedure	5 Participants	8 Participants

SECONDARY outcome

Timeframe: Within 1 year post study treatment

Population: Subjects with 12 month safety data

Freedom from procedure-related serious adverse events within one year of the index procedure

Outcome measures

Outcome measures
Measure	FIRM-only n=15 Participants Subjects in this arm will be treated with FIRM-guided conventional RF ablation without pulmonary vein isolation (PVI). FIRM-guided RF ablation	Conventional n=14 Participants Subjects in this arm will undergo conventional RF ablation with confirmation of PVI. Conventional RF ablation
Number of Participants With Freedom From Procedure-related Serious Adverse Events	12 Participants	14 Participants

Adverse Events

FIRM-only

Serious events: 12 serious events

Other events: 4 other events

Deaths: 0 deaths

Conventional

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	FIRM-only n=24 participants at risk Subjects in this arm will be treated with FIRM-guided conventional RF ablation without pulmonary vein isolation (PVI). FIRM-guided RF ablation	Conventional n=27 participants at risk Subjects in this arm will undergo conventional RF ablation with confirmation of PVI. Conventional RF ablation
Cardiac disorders Atrial Fibrillation	16.7% 4/24 • Number of events 4 • Adverse event data was collected up to 1 year post index procedure.	3.7% 1/27 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.

Additional Information

Clinical Program Director

Abbott

Phone: 6517566717

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The data and results from this study are the sole property of Sponsor. Investigators will not use data from this clinical investigation without the written consent of the Sponsor or generate publication materials as referenced in the Clinical Trial Agreement Single-center results are not allowed to be published or presented before the multi-center results.
Publication restrictions are in place

Restriction type: OTHER

Measure	FIRM-only n=24 participants at risk Subjects in this arm will be treated with FIRM-guided conventional RF ablation without pulmonary vein isolation (PVI). FIRM-guided RF ablation	Conventional n=27 participants at risk Subjects in this arm will undergo conventional RF ablation with confirmation of PVI. Conventional RF ablation
Cardiac disorders Atrial Fibrillation	4.2% 1/24 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.	0.00% 0/27 • Adverse event data was collected up to 1 year post index procedure.
Cardiac disorders Atrial Flutter	4.2% 1/24 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.	0.00% 0/27 • Adverse event data was collected up to 1 year post index procedure.
General disorders Accidental Exposure to Product	0.00% 0/24 • Adverse event data was collected up to 1 year post index procedure.	3.7% 1/27 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/24 • Adverse event data was collected up to 1 year post index procedure.	3.7% 1/27 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.
Vascular disorders Aneurysma Aorta Ascendens	0.00% 0/24 • Adverse event data was collected up to 1 year post index procedure.	3.7% 1/27 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.
Vascular disorders Aortic Valve Stenosis	0.00% 0/24 • Adverse event data was collected up to 1 year post index procedure.	3.7% 1/27 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.
Cardiac disorders Atrial Tachycardia	4.2% 1/24 • Number of events 2 • Adverse event data was collected up to 1 year post index procedure.	0.00% 0/27 • Adverse event data was collected up to 1 year post index procedure.
Vascular disorders Bleeding Aneamia	0.00% 0/24 • Adverse event data was collected up to 1 year post index procedure.	3.7% 1/27 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.
Metabolism and nutrition disorders Blood Sodium Decreased	0.00% 0/24 • Adverse event data was collected up to 1 year post index procedure.	3.7% 1/27 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.
Vascular disorders Carotid Artery Stenosis	4.2% 1/24 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.	0.00% 0/27 • Adverse event data was collected up to 1 year post index procedure.
Cardiac disorders Cardiac Failure	0.00% 0/24 • Adverse event data was collected up to 1 year post index procedure.	3.7% 1/27 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.
Vascular disorders Cerebral Infarction	0.00% 0/24 • Adverse event data was collected up to 1 year post index procedure.	3.7% 1/27 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chondromatosis	0.00% 0/24 • Adverse event data was collected up to 1 year post index procedure.	3.7% 1/27 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.
Vascular disorders Coronary Artery Disease	0.00% 0/24 • Adverse event data was collected up to 1 year post index procedure.	3.7% 1/27 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.
Vascular disorders Femoral Artery Occlusion	0.00% 0/24 • Adverse event data was collected up to 1 year post index procedure.	3.7% 1/27 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.
Vascular disorders Femoral Artery Aneurysm	4.2% 1/24 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.	0.00% 0/27 • Adverse event data was collected up to 1 year post index procedure.
General disorders Fracture Of Distale Radius Left, Orbita And Maxillary Sinus	4.2% 1/24 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.	0.00% 0/27 • Adverse event data was collected up to 1 year post index procedure.
Gastrointestinal disorders Gastroenteritis	4.2% 1/24 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.	0.00% 0/27 • Adverse event data was collected up to 1 year post index procedure.
Vascular disorders Hypertension	0.00% 0/24 • Adverse event data was collected up to 1 year post index procedure.	3.7% 1/27 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.
Vascular disorders Haematoma, Injection Site	8.3% 2/24 • Number of events 2 • Adverse event data was collected up to 1 year post index procedure.	0.00% 0/27 • Adverse event data was collected up to 1 year post index procedure.
Vascular disorders Haematoma, Right Groin	4.2% 1/24 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.	0.00% 0/27 • Adverse event data was collected up to 1 year post index procedure.
Hepatobiliary disorders Liver Abscess	4.2% 1/24 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.	0.00% 0/27 • Adverse event data was collected up to 1 year post index procedure.
Nervous system disorders Phrenic Nerve Paralysis	4.2% 1/24 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.	0.00% 0/27 • Adverse event data was collected up to 1 year post index procedure.
Vascular disorders Occlusion Of Arteria Femoralis Pop-Iii-Bypass Right Side	0.00% 0/24 • Adverse event data was collected up to 1 year post index procedure.	3.7% 1/27 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.
Vascular disorders Peripheral Ischaemia	0.00% 0/24 • Adverse event data was collected up to 1 year post index procedure.	3.7% 1/27 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.
Infections and infestations Pneumonia	4.2% 1/24 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.	3.7% 1/27 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.
Vascular disorders Syncope	0.00% 0/24 • Adverse event data was collected up to 1 year post index procedure.	7.4% 2/27 • Number of events 2 • Adverse event data was collected up to 1 year post index procedure.
Respiratory, thoracic and mediastinal disorders Pulmonary Fibrosis	4.2% 1/24 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.	0.00% 0/27 • Adverse event data was collected up to 1 year post index procedure.
Psychiatric disorders Suspected Dementia With Hospitalisation Due To Diagnostic Tests	4.2% 1/24 • Number of events 1 • Adverse event data was collected up to 1 year post index procedure.	0.00% 0/27 • Adverse event data was collected up to 1 year post index procedure.