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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

Sponsor
Farapulse, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05072964
Collaborator
(none)
180
Enrollment
16
Locations
1
Arm
30.3
Anticipated Duration (Months)
11.3
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: FARAPULSE Pulsed Field Ablation System
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 21, 2021
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: FARAPULSE Pulsed Field Ablation System

Ablation using the FARAPULSE Pulsed Field Ablation System

Device: FARAPULSE Pulsed Field Ablation System
A pulmonary vein isolation will be performed using catheter ablation
Other Names:
  • Ablation catheters indicated for Paroxysmal Atrial Fibrillation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    1. 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.

    2. Additional Performance Analyses: Acute Procedural Success; Acute Vein Success; Acute Chronic Success [12 Months]

      Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or Rescheduled Index Procedure)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 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 TTE/ICE

    • Presence of any cardiac valve prosthesis

    • Clinically significant mitral valve regurgitation or stenosis

    • Myocardial infarction, PCI / 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)

    • 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 followup

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jessa Ziekenhuis Hasselt Belgium
    2 Neuron Medical Brno Czechia
    3 Nemocnice Na Homolce Prague Czechia 150 30
    4 IKEM Cardiac Center Prague Czechia
    5 Copenhagen(Gentofte) Hospital Hellerup Denmark 2900
    6 Rhön Klinikum Bad Neustadt an der Saale Germany 97616
    7 Heart- and Diabetescenter NRW Bad Oeynhausen Germany
    8 UK Koln herzzentrum Cologne Germany
    9 Alfried Krupp Krankenhays Essen Germany 45131
    10 CCB Frankfurt Frankfurt Germany 60431
    11 Universitätsklinikum Hamburg-Eppendorf Hamburg Germany 20246
    12 Asklepios-Hamburg,Germany Hamburg Germany
    13 Catherina Eindhoven Netherlands 5623 EJ
    14 UMCG Groningen Netherlands 9713 GZ
    15 CUN Pamplona Spain
    16 Inselspital - Bern Bern Switzerland CH-3010

    Sponsors and Collaborators

    • Farapulse, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Farapulse, Inc.
    ClinicalTrials.gov Identifier:
    NCT05072964
    Other Study ID Numbers:
    • CS1169
    First Posted:
    Oct 11, 2021
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Farapulse, Inc.
    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
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Jul 27, 2022