The FARAPULSE FARA-Freedom Trial

Not Applicable

Completed

Conditions: Paroxysmal Atrial Fibrillation

Interventions: Device: FARAPULSE Pulsed Field Ablation System

Registration Number: NCT05072964

Lead Sponsor: Farapulse, Inc.

Brief Summary: The Post-Market Clinical Follow-Up trial is a prospective, multi-center, open-label, single-arm clinical follow-up study designed to provide long-term safety feasibility, effectiveness and performance of the FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF).

Detailed Description: The primary and secondary Safety, Feasibility, Effectiveness and Performance will be evaluated against pre-specified criteria as determined by the Sponsor and FDA. The criteria set in this study have been previously used to demonstrate Safety, Feasibility, Effectiveness and Performance in FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF).

The analysis of the primary safety and performance objective will take place once all the subjects with a study FARAPULSE Pulsed field ablation procedure attempt have reached 12 months of follow-up post-pulsed field ablation procedure.

The analyses of the primary effectiveness objective will take place once all the subjects with a study pulsed field ablation procedure attempt have reached 34 \~ 36 months of follow-up post-pulsed field ablation procedure.

The analyses for the secondary objectives will take place once all subjects with a study pulsed field ablation procedure attempt have reached 34\~36 months of follow-up post-pulsed field ablation procedure.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 180

Inclusion Criteria

Diagnosis of paroxysmal atrial fibrillation (PAF), AND
Two (2) or more episodes of recurrent PAF during the 6 months preceding the consent Date, AND
At least 1 episode of Atrial Fibrillation (AF) documented with a tracing within 12 months preceding the consent date.
Age 18 years or older
Therapeutic Failure for the treatment of Atrial Fibrillation (effectiveness or intolerance) of at least one active antiarrhythmic drug (AAD) for rhythm control.
Willing and Capable of providing Informed Consent to undergo study procedures AND
Participate in all examinations and follow-up visits and tests associated with this clinical study

Exclusion Criteria

Any previous left atrial (LA) ablation (except permissible retreatment subjects)
Any previous LA surgery
Current intracardiac thrombus (can be treated after thrombus is resolved)
Presence of any pulmonary vein stents
Presence of any pre-existing pulmonary vein stenosis
Body Mass Index (BMI) >45.0
Anteroposterior Left Atrial diameter > 5.5 cm by transthoracic echocardiography (TTE)/ intracardiac imaging (ICE)
Presence of any cardiac valve prosthesis
Clinically significant mitral valve regurgitation or stenosis
Myocardial infarction, percutaneous coronary intervention (PCI) / percutaneous transluminal coronary angiography (PTCA) or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date
Unstable angina
Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date
Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
New York Heart Association (NYHA) class III or IV congestive heart failure
Left ventricular ejection fraction (LVEF) < 35%
2º (Type II) or 3º atrioventricular block
Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
Hypertrophic cardiomyopathy
Active Systemic infection
Uncontrolled hyperthyroidism
Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date.
Any woman known to be pregnant
Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
Severe lung disease, pulmonary hypertension, or any lung disease associated with chronic abnormal blood gases or requiring supplemental oxygen
Renal insufficiency with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
Active malignancy, or history of treated malignancy within 24 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma)
Life expectancy less than one (1) year
Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study (data collection for registries or retrospective studies is permitted)
Unwilling or unable to comply fully with study procedures and follow-up
Clinically significant psychological condition that in the Investigator's opinion would prohibit the subject's ability to meet the protocol requirements
Other uncontrolled medical conditions that may modify device effect or increase risk, including uncontrolled diabetes mellitus, untreated sleep apnea or active alcohol abuse

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FARAPULSE Pulsed Field Ablation System	FARAPULSE Pulsed Field Ablation System	Ablation using the FARAPULSE Pulsed Field Ablation System

Primary Outcome Measures

Name	Time	Method
Effectiveness: Percentage of Participants Free of Chronic Treatment Failure Through 12 Months and Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter	12 Months	Evaluated by assessing the rate of subjects free of chronic treatment failure with paroxysmal atrial fibrillation who have failed one Antiarrhythmic Drugs (AAD). Includes both acute procedural success ( Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or or rescheduled index Procedure
Safety: Percentage of Participants Experiencing Composite Safety Endpoint(CSE) Through 12 Months	12 Months	To demonstrate safety of FARAPULSE Pulsed Field Ablation System, by assessing the rate of subjects experiencing Early and Late onset Composite Safety Endpoints(CSE) with paroxysmal atrial fibrillation who have therapeutic failure of at least one AntiArrhythmic Drug (AAD)

Secondary Outcome Measures

Name	Time	Method
Additional Safety Analyses: Percentage of Participants Free From Any of the Device or Procedure Related SAE	12 Months	Freedom from a serious adverse event (SAE) which has not been categorized as a Pulsed Field Ablation procedure event.
Additional Performance Analyses: Acute Procedural Success	1 day	Acute Procedural success is the demonstration of Acute Vein Success (measured by % subjects) was determined by Isolation of an ablated PVI using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or Rescheduled Index Procedure), as clinically assessed by entrance block demonstrated ≥ 20 minutes after the last PVI lesion is made with or without adenosine testing

Trial Locations

Locations (13): AZ Sint-Jan Brugee
🇧🇪
Brugge, Belgium
Jessa Ziekenhuis
🇧🇪
Hasselt, Belgium
Neuron Medical
🇨🇿
Brno, Czechia
Nemocnice Na Homolce
🇨🇿
Prague, Czechia
IKEM Cardiac Center
🇨🇿
Prague, Czechia
Copenhagen(Gentofte) Hospital
🇩🇰
Hellerup, Denmark
Heart- and Diabetescenter NRW
🇩🇪
Bad Oeynhausen, Germany
CCB Frankfurt
🇩🇪
Frankfurt, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪
Hamburg, Germany
Asklepios-Hamburg,Germany
🇩🇪
Hamburg, Germany
Catherina
🇳🇱
Eindhoven, Netherlands
UMCG
🇳🇱
Groningen, Netherlands
Inselspital - Bern
🇨🇭
Bern, Switzerland