CardioFocus HeartLight Post-Approval Study

NCT03168659 · tracked via the Priya Life Science USA tracker

Sponsor

CardioFocus

Phase

Not applicable

Started

2017-06-16

Last updated

2024-08-20

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

HeartLightAblation

HeartLight: HeartLight Endoscopic Ablation System

Ablation: Pulmonary vein isolation ablation

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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 — Day 91 through 12 months
The outcome will be assessed from 91 days post procedure through 12 months

Trial sites (4)

Facility	City	Region	Status
University of Arizona Sarver HeartCenter	Tucson	Arizona	Recruiting
University of Illinois	Chicago	Illinois	Recruiting
Mount Sinai Hospital	New York	New York	Recruiting
University Of Virginia Health System	Charlottesville	Virginia	Recruiting

Other trials for the same condition

SIMPLAAFY Clinical Trial Active, not recruiting

RESOLVE-AF: Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy. Active, not recruiting

Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation REFINE-PFA Recruiting

CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation Recruiting

Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03168659 on ClinicalTrials.gov ↗ ← All trials in the USA