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ADVENT-IDE

Trial Overview

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

Study Purpose

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.

Diagnosis

Atrial Fibrillation

Eligibility

Inclusion Criteria

  • atrial fibrillation
  • failed drug treatment

Exclusion Criteria

  • 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

Intervention

FARAPULSE Pulsed Field Ablation System

Key Participation Requirements
Trial Location(s)
Gender
Male or Female
Age
18 to 75
Enrollment Status
Recruiting
Phase
Not Applicable
Methodist Health System Trial Code
NCT04612244
Related Specialties