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Trial record 1 of 1 for:    NCT04612244
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04612244
Recruitment Status : Recruiting
First Posted : November 2, 2020
Last Update Posted : March 5, 2021
Information provided by (Responsible Party):
Farapulse, Inc.

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
Paroxysmal Atrial Fibrillation Device: FARAPULSE Pulsed Field Ablation System Device: RadioFrequency and Cryoballoon Ablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 1, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

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

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 [ Time Frame: 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 [ Time Frame: 12 Months ]
    Acute procedural success and Chronic success

Secondary Outcome Measures :
  1. PV Diameter change [ Time Frame: 3 months ]
    Change in pulmonary vein diameter

  2. Treatment Superiority [ Time Frame: 12 Months ]
    Treatment Success tested for superiority between the Pulsed Field and Thermal Groups.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04612244

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Contact: Kit Schneider 650-422-3633

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United States, Massachusetts
Massachusetts General Hospital (MGH) Recruiting
Boston, Massachusetts, United States, 02114
Contact: Grace Ha   
Contact: Song Kim   
Principal Investigator: Moussa Mansour, MD         
Sub-Investigator: Kevin Heist, MD         
United States, Michigan
UPMC Pinnacle Health Not yet recruiting
Harrisburg, Michigan, United States, 17105
Contact: Gretchen Meise   
Contact: Hillary Craig   
Principal Investigator: Chinmay Patel, MD         
Sub-Investigator: Michael Link, MD         
United States, Nebraska
Nebraska Methodist Health system, Inc Not yet recruiting
Omaha, Nebraska, United States, 68114
Contact: Dru McMartin   
Principal Investigator: Matthew Latacha, MD         
United States, New York
NYU Langone Health_Heart Rhythm Center Not yet recruiting
New York, New York, United States, 10016
Contact: April Jacob    212-263-7704   
Contact: Vivian Chao   
Principal Investigator: Larry A Chinitz, MD FACC FHRS         
Sub-Investigator: Douglas Holmes, MD         
Mount Sinai, Icahn School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Betsy Ellsworth   
Contact: Jeff Lam   
Principal Investigator: William Whang, MD         
Sub-Investigator: Srinivas Dukkipati, MD         
Sub-Investigator: Vivek Reddy, MD         
Northwell Health- Lenox Hill Hospital Recruiting
New York, New York, United States, 10075
Contact: Kristie Coleman   
Principal Investigator: Stavros Mountantonakis, MD         
Sub-Investigator: Nicolas Skipitaris, MD         
Sub-Investigator: Kabir Bhasin, MD         
United States, Pennsylvania
Doylestown Hospital Not yet recruiting
Doylestown, Pennsylvania, United States, 18901
Contact: Linda Schwartz   
Contact: Vera McKinney   
United States, Texas
St Davids_Texas Cardiac Arrhythmia Research Foundation Not yet recruiting
Austin, Texas, United States, 78705
Contact: Deb Cardinal   
Principal Investigator: Andrea Natale, MD         
Sub-Investigator: Gerald Gallinghouse, MD         
Sponsors and Collaborators
Farapulse, Inc.
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Responsible Party: Farapulse, Inc. Identifier: NCT04612244    
Other Study ID Numbers: CS0934
First Posted: November 2, 2020    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes