Recruiting

CardioFocus

Sponsor:

CardioFocus

Code:

NCT03168659

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HeartLight

Ablation

Study Details

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.

Conditions

Atrial Fibrillation

Study ID

NCT03168659

Start date

Jun 16, 2017

Status verified date

Aug, 2024

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

250 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Treatment

Pulmonary vein isolation ablation with HeartLight Endoscopic Ablation System

Interventions

HeartLight

HeartLight Endoscopic Ablation System

Ablation

Pulmonary vein isolation ablation

Primary outcome measure

  • 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 [ Time Frame: Day 91 through 12 months ]

Central Contacts and Locations

Central contacts

Study Director

508-658-7253lhausmann@cardiofocus.com

Locations

University of Arizona Sarver HeartCenter

Recruiting

Tucson, Arizona, United States, 85724

Principal Investigator:

Mathew Hutchinson, MD

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Principal Investigator:

Erik Wissner, MD

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Betsy Ellsworth, MSN, ANP

betsy.ellsworth@mountsinai.org

Principal Investigator:

Srini Dukkipati, MD

University Of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Mary Jane Strickland

434-982-6401MJS7W@hscmail.mcc.virginia.edu

Principal Investigator:

J. Michael Mangrum, MD

More Information

Sponsor

CardioFocus

Last update posted

Aug 20, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CardioFocus on 2024-08-20.