CardioFocus HeartLight Post-Approval Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HeartLight, Ablation.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Post-Approval Study of the HeartLight Endoscopic Ablation System for the Treatment of Atrial Fibrillation
Overview
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.
Interventions
- Device HeartLight
HeartLight Endoscopic Ablation System - Procedure Ablation
Pulmonary vein isolation ablation
Primary outcome measures
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- University of Arizona Sarver HeartCenter — Tucson
- University of Illinois — Chicago
- Mount Sinai Hospital — New York
- University Of Virginia Health System — Charlottesville
Identifiers
NCT: NCT03168659 · 25-3944