CardioFocus HeartLight Post-Approval Study

Atrial Fibrillation Clinical Trial

Official title:

Post-Approval Study of the HeartLight Endoscopic Ablation System for the Treatment of Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03168659
• Other study ID #: 25-3944
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2017
• Est. completion date: October 2026

Study information

• Verified date: March 2023
• Source: CardioFocus
• Contact: Study Director
• Phone: 508-658-7253
• Email: lhausmann[@]cardiofocus.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 2026
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• HeartLight
HeartLight Endoscopic Ablation System

Procedure:
• Ablation
Pulmonary vein isolation ablation

Locations

Country	Name	City	State
United States	University Of Virginia Health System	Charlottesville	Virginia
United States	University of Illinois	Chicago	Illinois
United States	Mount Sinai Hospital	New York	New York
United States	University of Arizona Sarver HeartCenter	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
CardioFocus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Chronic Effectiveness	Freedom from symptomatic AF or symptomatic atypical AFL/AT	36 months
Other	Chronic Safety	Reporting of adverse events	36 months
Other	Effect of Operator Experience on primary effectiveness endpoint	Assess relationship between operator experience and freedom from symptomatic AF or symptomatic atypical AFL/AT	36 months
Other	Effect of Operator Experience on primary safety endpoint	Assess relationship between operator experience and rate of Primary Adverse Events (PAE)	36 months
Other	Safety Outcomes by Gender	Assess relationship between gender and rate of PAEs	12 months and 36 months
Other	Neurological Events	Assess relationship between neurological events and procedural parameters	36 months
Primary	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	The outcome will be assessed from 91 days post procedure through 12 months	Day 91 through 12 months