The FARAPULSE FARA-Freedom Trial

NCT ID: NCT05072964

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-21
• Study Completion Date: 2023-10-19

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.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FARAPULSE Pulsed Field Ablation System

Ablation using the FARAPULSE Pulsed Field Ablation System

Group Type: OTHER

FARAPULSE Pulsed Field Ablation System

Intervention Type: DEVICE

A pulmonary vein isolation will be performed using catheter ablation

Interventions

FARAPULSE Pulsed Field Ablation System

A pulmonary vein isolation will be performed using catheter ablation

Intervention Type: DEVICE

Other Intervention Names

Ablation catheters indicated for Paroxysmal Atrial Fibrillation

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AZ Sint-Jan Brugee

Bruges, , 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

Countries

Belgium; Czechia; Denmark; Germany; Netherlands; Switzerland

References

Metzner A, Fiala M, Vijgen J, Ouss A, Gunawardene M, Hansen J, Kautzner J, Schmidt B, Duytschaever M, Reichlin T, Blaauw Y, Sommer P, Vanderper A, Achyutha AB, Johnson M, Raybuck JD, Neuzil P. Long-term outcomes of the pentaspline pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation: results of the prospective, multicentre FARA-Freedom Study. Europace. 2024 Mar 1;26(3):euae053. doi: 10.1093/europace/euae053.

Reference Type: DERIVED

PMID: 38385529 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CS1169

Identifier Type: -

Identifier Source: org_study_id