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

Not Applicable

Completed

• Conditions: Paroxysmal Atrial Fibrillation

• Registration Number: NCT04612244
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-10-30
• Study First Posted: 2020-11-02
• Study Start: 2021-03-01
• Primary Completion: 2023-05-15
• Study Completion: 2023-05-15
• Results First Submitted: 2024-05-27
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-14
• Last Update Submitted: 2024-11-14
• Results First Posted: 2024-11-20
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 706

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint	12-Months	Treatment Success: The primary effectiveness endpoint is Treatment Success in MITT Subjects, defined as: 1. Acute Procedural Success AND; 2. Chronic Success, defined as freedom from: 1. At the Index / Rescheduled Index Procedure: Use of a non-randomized treatment modality for PVI; 2. After the Blanking Period: i. Occurrence of any Detectable AF, AFL or AT (excluding CTI-dependent flutter confirmed by EP study); ii. Any cardioversion for AF, AFL or AT (excluding for CTI-dependent flutter); iii. Use of any Type I or Type III antiarrhythmic medication for the treatment of AF, AFL or AT; c. At any time: i. Re-ablation for AF, AFL or AT (other than for CTI-dependent flutter); ii. Use of amiodarone, except intra-procedurally to control an arrhythmia Endpoint status will be assessed through the Month 12 Assessment (Day 360 ± 30).
Composite Safety Endpoint;Proportion of MITT 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

Secondary Outcome Measures

Name	Time	Method
Change in PV Cross-sectional Area	3 months	Mean change in aggregate PV Cross-Sectional area (cm\^2) from baseline to Day 90
Primary Effectiveness Treatment Success Tested for Superiority	12 Months	The secondary effectiveness endpoint is the same as the primary effectiveness endpoint but will be tested for superiority rather than non-inferiority. The proportion of Pulsed Field Subjects with Treatment Success will be assessed for superiority to the proportion of Thermal Subjects with Treatment Success.

Trial Locations

Locations (34)

Grandview Medical Center; 🇺🇸 Birmingham, Alabama, United States

The University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Banner University Medical Center; 🇺🇸 Phoenix, Arizona, United States

HonorHealth Scottsdale Shea; 🇺🇸 Scottsdale, Arizona, United States

Scripps Memorial Hospital La Jolla; 🇺🇸 La Jolla, California, United States

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

University of California San Francisco (UCSF); 🇺🇸 San Francisco, California, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

St Luke's Regional Medical Center; 🇺🇸 Boise, Idaho, United States

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

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