Health TrialsbyHealthPanel

CardioFocus HeartLight Post-Approval Study

ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCardioFocus

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older

planned for catheter ablation due to symptomatic paroxysmal atrial fibrillation

failure of at least one anti-arrhythmic drug

others

Disqualifiers

overall good health as established by multiple criteria

Trial design

Design model

Single group

Treatments tested in this trial

  • HeartLight

    Device

    HeartLight Endoscopic Ablation System

  • Ablation

    Procedure/Surgery

    Pulmonary vein isolation ablation

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: TreatmentOther 2 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
Day 91 through 12 months

Secondary outcomes

Other outcomes

1

Chronic Effectiveness

Freedom from symptomatic AF or symptomatic atypical AFL/AT

Time frame
36 months
2

Chronic Safety

Reporting of adverse events

Time frame
36 months
3

Effect of Operator Experience on primary effectiveness endpoint

Assess relationship between operator experience and freedom from symptomatic AF or symptomatic atypical AFL/AT

Time frame
36 months
4

Effect of Operator Experience on primary safety endpoint

Assess relationship between operator experience and rate of Primary Adverse Events (PAE)

Time frame
36 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CardioFocus

Lead sponsor

Source ClinicalTrials.gov
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