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CardioFocus HeartLight Post-Approval Study

CardioFocus · NCT03168659

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
250
US sites recruiting
4
Study start
June 16, 2017
Record last updated
August 20, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: HeartLight; Ablation

Conditions: Atrial Fibrillation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • University of Arizona Sarver HeartCenter

    Tucson, AZ 85724

    Site contact: Mathew Hutchinson, MD

  • University of Illinois

    Chicago, IL 60612

    Site contact: Erik Wissner, MD

  • Mount Sinai Hospital

    New York, NY 10029

    Site contact: Betsy Ellsworth, MSN, ANP · betsy.ellsworth@mountsinai.org

  • University Of Virginia Health System

    Charlottesville, VA 22908

    Site contact: Mary Jane Strickland · 434-982-6401 · MJS7W@hscmail.mcc.virginia.edu

Study contacts (from the official record)

  • Study Director · 508-658-7253 · lhausmann@cardiofocus.com
All heart & blood pressure studies in Arizona →
CardioFocus HeartLight Post-Approval Study (NCT03168659) | Bored Studies