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The FARAPULSE ADVENT PIVOTAL Trial (ADVENT)

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.
 
ClinicalTrials.gov Identifier: NCT04612244
Recruitment Status : Recruiting
First Posted : November 2, 2020
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Farapulse, Inc.

Tracking Information
First Submitted Date  ICMJE October 26, 2020
First Posted Date  ICMJE November 2, 2020
Last Update Posted Date April 29, 2021
Actual Study Start Date  ICMJE March 1, 2021
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2021)
  • 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
  • Treatment success [ Time Frame: 12 Months ]
    Acute procedural success and Chronic success
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2021)
  • PV Diameter change [ Time Frame: 3 months ]
    Change in pulmonary vein diameter
  • Treatment Superiority [ Time Frame: 12 Months ]
    Treatment Success tested for superiority between the Pulsed Field and Thermal Groups.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The FARAPULSE ADVENT PIVOTAL Trial
Official Title  ICMJE A Prospective Randomized Pivotal Trial of the FARAPULSE Pulsed Field Ablation System Compared With Standard of Care Ablation in Patients With Paroxysmal Atrial Fibrillation
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Paroxysmal Atrial Fibrillation
Intervention  ICMJE
  • Device: FARAPULSE Pulsed Field Ablation System
    Ablation using the FARAPULSE Pulsed Field Ablation System
  • Device: RadioFrequency and Cryoballoon Ablation
    Contact Force Enabled RF and Cryoballoon ablation catheters indicated for Paroxysmal Atrial Fibrillation
Study Arms  ICMJE
  • Experimental: FARAPULSE Pulsed Field Ablation System
    Intervention: Device: FARAPULSE Pulsed Field Ablation System
  • Active Comparator: Force Sensing Radiofrequency Ablation and Cryoballoon Ablation
    Intervention: Device: RadioFrequency and Cryoballoon Ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 25, 2021)
900
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kit Schneider 650-422-3633 kschneider@farapulse.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04612244
Other Study ID Numbers  ICMJE CS0934
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Farapulse, Inc.
Study Sponsor  ICMJE Farapulse, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Farapulse, Inc.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP