NCT05072964

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
6 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 11, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 21, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2023

Completed
12 months until next milestone

Results Posted

Study results publicly available

October 17, 2024

Completed
Last Updated

October 17, 2024

Status Verified

October 1, 2024

Enrollment Period

1.8 years

First QC Date

September 29, 2021

Results QC Date

May 27, 2024

Last Update Submit

October 15, 2024

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Catheter AblationPulmonary Vein Isolation (PVI)Atrial Fibrillation (AF)Atrial FlutterAtrial TachycardiaPulsed Field AblationCavo-tricuspid isthmusAnti-arrhythmic drugsAtrial Fibrillation DrugsCardiac ArrhythmiasCardiac AblationCardiovascular DiseasesHeart Diseases

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    12 Months

  • Safety: Percentage of Participants Experiencing Composite Safety Endpoint(CSE) Through 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)

    12 Months

Secondary Outcomes (2)

  • Additional Safety Analyses: Percentage of Participants Free From Any of the Device or Procedure Related SAE

    12 Months

  • Additional Performance Analyses: Acute Procedural Success

    1 day

Study Arms (1)

FARAPULSE Pulsed Field Ablation System

OTHER

Ablation using the FARAPULSE Pulsed Field Ablation System

Device: FARAPULSE Pulsed Field Ablation System

Interventions

FARAPULSE Pulsed Field Ablation SystemDEVICE

A pulmonary vein isolation will be performed using catheter ablation

Also known as: Ablation catheters indicated for Paroxysmal Atrial Fibrillation
FARAPULSE Pulsed Field Ablation System

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

AZ Sint-Jan Brugee

Bruges, Belgium

Location

Jessa Ziekenhuis

Hasselt, Belgium

Location

Neuron Medical

Brno, Czechia

Location

Nemocnice Na Homolce

Prague, 150 30, Czechia

Location

IKEM Cardiac Center

Prague, Czechia

Location

Copenhagen(Gentofte) Hospital

Hellerup, 2900, Denmark

Location

Heart- and Diabetescenter NRW

Bad Oeynhausen, Germany

Location

CCB Frankfurt

Frankfurt, 60431, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Asklepios-Hamburg,Germany

Hamburg, Germany

Location

Catherina

Eindhoven, 5623 EJ, Netherlands

Location

UMCG

Groningen, 9713 GZ, Netherlands

Location

Inselspital - Bern

Bern, CH-3010, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 38385529DERIVED

MeSH Terms

Conditions

Atrial FibrillationAtrial FlutterArrhythmias, CardiacCardiovascular DiseasesHeart Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Allison Anderson
Organization
FARAPULSE
Allison.Anderson@bsci.com
651-582-5077

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 11, 2021

Study Start

December 21, 2021

Primary Completion

October 12, 2023

Study Completion

October 19, 2023

Last Updated

October 17, 2024

Results First Posted

October 17, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(4)CZ(3)CH(1)BE(2)DK(1)NL(2)