The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation

Sponsor
Farapulse, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04612244
Collaborator
(none)
900
31
2
27
29
1.1

Study Details

Study Description

Brief Summary

This is a prospective, adaptive, multi-center, randomized safety and effectiveness pivotal study comparing the FARAPULSE Pulsed Field Ablation System with standard of care ablation with force-sensing RF catheters and cryoballoon catheters indicated for the treatment of PAF.

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
900 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Prospective Randomized Pivotal Trial of the FARAPULSE Pulsed Field Ablation System Compared With Standard of Care Ablation in Patients With Paroxysmal Atrial Fibrillation
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: FARAPULSE Pulsed Field Ablation System

Device: FARAPULSE Pulsed Field Ablation System
Ablation using the FARAPULSE Pulsed Field Ablation System

Active Comparator: Force Sensing Radiofrequency Ablation and Cryoballoon Ablation

Device: RadioFrequency and Cryoballoon Ablation
Contact Force Enabled RF and Cryoballoon ablation catheters indicated for Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcome Measures

  1. Composite Safety Endpoint;Proportion of Intent to Treat Subjects with one or more of the specified device or procedure related SAEs [7 days and 12 Months]

    Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEs

  2. Treatment success [12 Months]

    Acute procedural success and Chronic success

Secondary Outcome Measures

  1. PV Diameter change [3 months]

    Change in pulmonary vein diameter

  2. Treatment Superiority [12 Months]

    Treatment Success tested for superiority between the Pulsed Field and Thermal Groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Key inclusion criteria: Patients are required to meet all the following inclusion criteria to participate in this study:

  • Age 18-75

  • Paroxysmal atrial fibrillation

  • Anti-arrhythmic drug failed for efficacy or intolerance

Key exclusion criteria: Patients will be excluded from participating in this study if they meet any one of the following exclusion criteria:

  • Atrial diameter greater than 5.5 cm

  • Prior atrial ablation or surgery

  • Left ventricular ejection fraction < 40%

  • Implantable cardiac devices

  • Heart surgery or stroke within 6 months of enrollment

  • Renal impairment

  • Body mass index greater than 40

Contacts and Locations

Locations

Site City State Country Postal Code
1 Grandview Medical Center Birmingham Alabama United States 35243
2 The University of Alabama Birmingham Alabama United States 35294
3 Banner University Medical Center Phoenix Arizona United States 85006
4 Scripps Memorial Hospital La Jolla La Jolla California United States 92037
5 California Pacific Medical Center San Francisco California United States 94109
6 University of California San Francisco (UCSF) San Francisco California United States 94143
7 Emory Saint Joseph's Hospital Atlanta Georgia United States 30322
8 St Luke's Regional Medical Center Boise Idaho United States 83712
9 Johns Hopkins Baltimore Maryland United States 21287
10 Massachusetts General Hospital (MGH) Boston Massachusetts United States 02114
11 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
12 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
13 Nebraska Methodist Health system, Inc Omaha Nebraska United States 68114
14 Catholic Medical Center Manchester New Hampshire United States 03102
15 NYU Langone Health_Heart Rhythm Center New York New York United States 10016
16 Mount Sinai, Icahn School of Medicine New York New York United States 10029
17 Northwell Health- Lenox Hill Hospital New York New York United States 10075
18 Duke University Medical Center Durham North Carolina United States 27710
19 Providence St Vincent Medical Center, Heart and Vascular Clinical Trials Portland Oregon United States 97225
20 Doylestown Hospital Doylestown Pennsylvania United States 18901
21 Penn Presbyterian Medical Center Philadelphia Pennsylvania United States 19104
22 University of Pennsylvania Philadelphia Pennsylvania United States 19104
23 UPMC Pinnacle Health Wormleysburg Pennsylvania United States 17105
24 Trident Medical Center Charleston South Carolina United States 29406
25 Medical University of South Carolina Charleston South Carolina United States 29425
26 Saint Thomas Health Nashville Tennessee United States 37205
27 Vanderbilt University Medical Center Nashville Tennessee United States 37212
28 St Davids_Texas Cardiac Arrhythmia Research Foundation Austin Texas United States 78705
29 University of Virginia Charlottesville Virginia United States 22903
30 Virginia Commonwealth University Richmond Virginia United States 23298
31 MedStar Washington Hospital Center Northwest Washington United States 20010

Sponsors and Collaborators

  • Farapulse, Inc.

Investigators

  • Principal Investigator: Vivek Reddy, MD, Mt. Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Farapulse, Inc.
ClinicalTrials.gov Identifier:
NCT04612244
Other Study ID Numbers:
  • CS0934
First Posted:
Nov 2, 2020
Last Update Posted:
Jul 26, 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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 26, 2022