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Trial record 1 of 1 for:    NCT04612244
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The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation (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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04612244
Recruitment Status : Active, not recruiting
First Posted : November 2, 2020
Last Update Posted : June 2, 2023
Sponsor:
Information provided by (Responsible Party):
Farapulse, Inc.

Study Description
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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

Study Design
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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


Arms and Interventions
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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
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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.


Eligibility Criteria
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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
Criteria

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
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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 ClinicalTrials.gov identifier (NCT number): NCT04612244


Locations
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Sponsors and Collaborators
Farapulse, Inc.
Investigators
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Principal Investigator: Vivek Reddy, MD Mt. Sinai
More Information
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Responsible Party: Farapulse, Inc.
ClinicalTrials.gov Identifier: NCT04612244    
Other Study ID Numbers: CS0934
First Posted: November 2, 2020    Key Record Dates
Last Update Posted: June 2, 2023
Last Verified: May 2023
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