The FARAPULSE FARA-Freedom Trial

Farapulse

Status

Completed

Conditions

Paroxysmal Atrial Fibrillation

Treatments

Device: FARAPULSE Pulsed Field Ablation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05072964

CS1169

Details and patient eligibility

About

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).

Full 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.

Enrollment

180 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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