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NCT Number: NCT03168659

CardioFocus HeartLight Post-Approval Study

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona Sarver HeartCenter, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HeartLight

Device

HeartLight Endoscopic Ablation System

Ablation

Procedure

Pulmonary vein isolation ablation

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

    Time frame: Day 91 through 12 months

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

Other outcomes

  1. Chronic Effectiveness

    Time frame: 36 months

    Freedom from symptomatic AF or symptomatic atypical AFL/AT

  2. Chronic Safety

    Time frame: 36 months

    Reporting of adverse events

  3. Effect of Operator Experience on primary effectiveness endpoint

    Time frame: 36 months

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

  4. Effect of Operator Experience on primary safety endpoint

    Time frame: 36 months

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

  5. Safety Outcomes by Gender

    Time frame: 12 months and 36 months

    Assess relationship between gender and rate of PAEs

  6. Neurological Events

    Time frame: 36 months

    Assess relationship between neurological events and procedural parameters

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

508-658-7253

Sponsors and collaborators

Lead sponsor

CardioFocus

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2028
First posted
May 30, 2017
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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