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

NCT04612244 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 706

Last updated 2024-11-20

Study results available
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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.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Vivek Reddy, MD · Mt. Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-05-15
Completion
2023-05-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04612244 on ClinicalTrials.gov