CardioFocus HeartLight Post-Approval Study

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03168659

Enrollment

250

Registered

2017-05-30

Start date

2017-06-16

Completion date

2028-10-31

Last updated

2024-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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.

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

DEVICEHeartLight

HeartLight Endoscopic Ablation System

PROCEDUREAblation

Pulmonary vein isolation ablation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Other

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

Countries

United States

Contacts

Primary ContactStudy Director

lhausmann@cardiofocus.com508-658-7253

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026