CardioFocus HeartLight Post-Approval Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: HeartLight; Procedure: Ablation

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 Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Director; Phone Number: 508-658-7253; Email: lhausmann@cardiofocus.com

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Recruiting
      • University of Arizona Sarver HeartCenter
      • Principal Investigator: Mathew Hutchinson, MD
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois
      • Principal Investigator: Erik Wissner, MD
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Betsy Ellsworth, MSN, ANP; Email: Betsy.ellsworth@mountsinai.org
      • Principal Investigator: Srini Dukkipati, MD
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia Health System
      • Contact: Mary Jane Strickland; Phone Number: 434-982-6401; Email: MJS7W@hscmail.mcc.virginia.edu
      • Principal Investigator: J. Michael Mangrum, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment; Pulmonary vein isolation ablation with HeartLight Endoscopic Ablation System	Device: HeartLight; HeartLight Endoscopic Ablation System; Procedure: Ablation; Pulmonary vein isolation ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic Effectiveness	Freedom from symptomatic AF or symptomatic atypical AFL/AT	36 months
Chronic Safety	Reporting of adverse events	36 months
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
Effect of Operator Experience on primary safety endpoint	Assess relationship between operator experience and rate of Primary Adverse Events (PAE)	36 months
Safety Outcomes by Gender	Assess relationship between gender and rate of PAEs	12 months and 36 months
Neurological Events	Assess relationship between neurological events and procedural parameters	36 months

Collaborators and Investigators

• Sponsor: CardioFocus

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2017
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: May 24, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 25-3944

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No