CardioFocus HeartLight Post-Approval Study

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation
• Interventions: Device: HeartLight; Procedure: Ablation

• Registration Number: NCT03168659
• Lead Sponsor: CardioFocus

Brief Summary

This is a post-approval study to evaluate the clinical outcomes in a cohort of participants treated during commercial use of the HeartLight System to confirm results of the previously conducted pivotal clinical study.

Detailed Description

This is a prospective, open-label, multi-center, single arm study designed to assess continued safety and effectiveness of the HeartLight System during commercial use in participants being treated for drug refractory, symptomatic, paroxysmal atrial fibrillation.

Study Timeline

• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-05-25
• Study First Posted: 2017-05-30
• Study Start: 2017-06-16
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2026-10
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• 18 years or older
• planned for catheter ablation due to symptomatic paroxysmal atrial fibrillation
• failure of at least one anti-arrhythmic drug
• others

Exclusion Criteria

• overall good health as established by multiple criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Ablation	Pulmonary vein isolation ablation with HeartLight Endoscopic Ablation System
Treatment	HeartLight	Pulmonary vein isolation ablation with HeartLight Endoscopic Ablation System

Primary Outcome Measures

Name	Time	Method
The proportion of participants free from symptomatic atrial fibrillation (AF) or symptomatic atypical atrial flutter/atrial tachycardia (AFL/AT) lasting longer than 30 seconds post the 90 day blanking period	Day 91 through 12 months	The outcome will be assessed from 91 days post procedure through 12 months

Trial Locations

Locations (4)

University Of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States

University of Arizona Sarver HeartCenter; 🇺🇸 Tucson, Arizona, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States

University of Illinois; 🇺🇸 Chicago, Illinois, United States