NCT03168659 · CardioFocus
CardioFocus HeartLight Post-Approval Study
What this study is about
This is a post-approval study to evaluate the clinical outcomes in a group of participants of participants treated during commercial use of the HeartLight System to confirm results of the previously conducted pivotal clinical study.
View original scientific description
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.
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
The outcome will be assessed from 91 days post procedure through 12 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18 years or older
- planned for catheter ablation due to symptomatic paroxysmal atrial fibrillation
- failure of at least one anti-arrhythmic drug
Exclusion criteria
- overall good health as established by multiple criteria
Where
- Tucson, Arizona
- Chicago, Illinois
- New York, New York
- Charlottesville, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 20, 2024 · Source of record for eligibility and locations