Clinical trial NCT05072964: The FARAPULSE FARA-Freedom Trial
Official title: The FARAPULSE FARA-Freedom Trial A Prospective Open Label Single Arm Post Market Clinical Follow-Up Trial of the FARAPULSE Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Catheter Ablation
Pulmonary Vein Isolation (PVI)
Atrial Fibrillation (AF)
Atrial Flutter
Atrial Tachycardia
Pulsed Field Ablation
Cavo-tricuspid isthmus
Anti-arrhythmic drugs
Atrial Fibrillation Drugs
Cardiac Arrhythmias
Cardiac Ablation
Cardiovascular Diseases
Heart Diseases
Lead sponsor: Farapulse, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-11
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 12 Months
measure: Safety: Percentage of Participants Experiencing Composite Safety Endpoint(CSE) Through 12 Months
timeFrame: 12 Months
Secondary outcomes:
measure: Additional Safety Analyses: Percentage of Participants Free From Any of the Device or Procedure Related SAE
timeFrame: 12 Months
measure: Additional Performance Analyses: Acute Procedural Success
timeFrame: 1 day
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugee
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Brno
country: Czechia
facility: Neuron Medical
city: Prague
country: Czechia
facility: Nemocnice Na Homolce
city: Prague
country: Czechia
facility: IKEM Cardiac Center
city: Hellerup
country: Denmark
facility: Copenhagen(Gentofte) Hospital
city: Bad Oeynhausen
country: Germany
facility: Heart- and Diabetescenter NRW
city: Frankfurt
country: Germany
facility: CCB Frankfurt
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Asklepios-Hamburg,Germany
city: Eindhoven
country: Netherlands
facility: Catherina
city: Groningen
country: Netherlands
facility: UMCG
city: Bern
country: Switzerland
facility: Inselspital - Bern
Study officials:
References: