Trial Outcomes & Findings for A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation (NCT NCT03714178)

Last Updated: 2022-05-04

Results Overview

Early onset (within 30 days of any endocardial ablation for atrial fibrillation). Occurrence of any one of the below events will qualify a subject as a safety failure. * Death * Myocardial infarction (MI) * Persistent diaphragmatic paralysis * Stroke or transient ischemic attack (TIA) * Peripheral or organ thromboembolism * Pericarditis * Cardiac tamponade / perforation * Vascular access complications * Hospitalization (initial or prolonged)\* * Heart block * Late onset (any time during follow-up) * Pulmonary vein (PV) stenosis (\> 70% diameter reduction from baseline) * Atrio-esophageal fistula \* Excludes hospitalization (initial \& prolonged) solely due to arrhythmia (AF/Atrial Flutter/Atrial Tachycardia) recurrence or due to non-urgent cardioversion (pharmacological or electrical).

Recruitment status

COMPLETED

Study phase

Target enrollment

71 participants

Primary outcome timeframe

30 days~12 Months

Results posted on

2022-05-04

Participant Flow

Participant milestones

Participant milestones
Measure	FARAPULSE Endocardial Ablation Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation. FARAPULSE Endocardial Ablation System: Endocardial ablation using the FARAPULSE Endocardial Ablation System.
Overall Study STARTED	71
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FARAPULSE Endocardial Ablation n=71 Participants Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation. FARAPULSE Endocardial Ablation System: Endocardial ablation using the FARAPULSE Endocardial Ablation System.
Age, Continuous	57.2 years STANDARD_DEVIATION 10.5 • n=71 Participants
Sex: Female, Male Female	15 Participants n=71 Participants
Sex: Female, Male Male	56 Participants n=71 Participants
Region of Enrollment Czechia	50 participants n=71 Participants
Region of Enrollment France	21 participants n=71 Participants
BMI	28.3 kg/m^2 STANDARD_DEVIATION 4.4 • n=71 Participants
Left atrial diameter	4.1 cm STANDARD_DEVIATION 0.5 • n=71 Participants
Atrial Fibrillation history (number of months)	16.61 months STANDARD_DEVIATION 23.94 • n=71 Participants
LVEF %	62.1 percentage of left ventricular ejection STANDARD_DEVIATION 6.3 • n=71 Participants
CHA2DS2VASC	1.8 units on a scale STANDARD_DEVIATION 1.6 • n=71 Participants
Patient that failed any AntiArrhythmic Drugs	69 Participants n=71 Participants
Smoking	38 Participants n=71 Participants
Dyslipidemia	24 Participants n=71 Participants
COPD	1 Participants n=71 Participants
PPM/ICD	0 Participants n=71 Participants
Unstable angina	0 Participants n=71 Participants
NYHA Heart Failure Class I	18 Participants n=71 Participants
NYHA Heart Failure Class II	3 Participants n=71 Participants
NYHA Heart Failure Class III	0 Participants n=71 Participants
NYHA Heart Failure Class IV	0 Participants n=71 Participants
Any History of Structural heart disease	3 Participants n=71 Participants
Cerebrovascular disease	6 Participants n=71 Participants
Cardiac Surgery	2 Participants n=71 Participants
Diabetes	7 Participants n=71 Participants
Hypertension	42 Participants n=71 Participants
Hyperthyroidism	3 Participants n=71 Participants
Hypothyroidism	9 Participants n=71 Participants
Myocardial infarction	3 Participants n=71 Participants
Peripheral vascular disease	3 Participants n=71 Participants
Pulmonary hypertension	0 Participants n=71 Participants
Renal dysfunction/failure	1 Participants n=71 Participants
Sleep apnea	3 Participants n=71 Participants

PRIMARY outcome

Timeframe: 30 days~12 Months

Outcome measures

Outcome measures
Measure	FARAPULSE Endocardial Ablation n=71 Participants Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation. FARAPULSE Endocardial Ablation System: Endocardial ablation using the FARAPULSE Endocardial Ablation System.
The Primary Safety Endpoint for This Study is the Composite Safety Endpoint (CSE) Defined as the Proportion of Patients With Early-onset and Late-onset Serious Adverse Events (SAEs) Which Are Device- or Procedure-related.	2 Participants

SECONDARY outcome

Timeframe: 1 Day (Acute)

The proportion of subjects that achieve Acute Procedural Success (APS) defined as the percutaneous endocardial creation of a complete, electrically isolating set of lesions around the ostia of the pulmonary veins (PVI) using the FARAPULSE Endocardial Ablation System during the first procedure, as clinically assessed by entrance and/or exit block performed ≥ 20 minutes after the last PVI lesion is made.

Outcome measures

Outcome measures
Measure	FARAPULSE Endocardial Ablation n=71 Participants Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation. FARAPULSE Endocardial Ablation System: Endocardial ablation using the FARAPULSE Endocardial Ablation System.
Feasibility: Pulmonary Vein Isolation	1.0 Proportion of participants

Adverse Events

FARAPULSE Endocardial Ablation

Serious events: 11 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FARAPULSE Endocardial Ablation n=71 participants at risk Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation. FARAPULSE Endocardial Ablation System: Endocardial ablation using the FARAPULSE Endocardial Ablation System.
Cardiac disorders Atrial Fibrillation	1.4% 1/71 • Number of events 1 • 12 months
Cardiac disorders Atrial Flutter	1.4% 1/71 • Number of events 1 • 12 months
Cardiac disorders Palpitations	1.4% 1/71 • Number of events 1 • 12 months
Cardiac disorders Pericardial Effusion	1.4% 1/71 • Number of events 1 • 12 months
Vascular disorders Air Embolism	1.4% 1/71 • Number of events 1 • 12 months
Vascular disorders Arteriovenous Fistula	2.8% 2/71 • Number of events 2 • 12 months
Gastrointestinal disorders Inguinal Hernia	2.8% 2/71 • Number of events 2 • 12 months
Musculoskeletal and connective tissue disorders Back Pain	1.4% 1/71 • Number of events 1 • 12 months
Surgical and medical procedures Cardioversion	1.4% 1/71 • Number of events 1 • 12 months

Other adverse events

Other adverse events
Measure	FARAPULSE Endocardial Ablation n=71 participants at risk Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation. FARAPULSE Endocardial Ablation System: Endocardial ablation using the FARAPULSE Endocardial Ablation System.
Gastrointestinal disorders Chronic Gastritis	12.7% 9/71 • 12 months
General disorders Oedema peripheral	5.6% 4/71 • Number of events 71 • 12 months
Cardiac disorders Palpitations	5.6% 4/71 • 12 months

Additional Information

Kit Schneider

Farapulse

Phone: 617-686-7661

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place