HeartLight Ablation for Atrial Fibrillation

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: CardioFocus

Must be taking: Anti-arrhythmics

Disqualifiers: Good health, others

No Placebo Group

Trial Summary

What is the purpose of 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.

Do I need to stop my current medications for the HeartLight Ablation trial?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment HeartLight Ablation for Atrial Fibrillation?

Research shows that cryoablation, a type of treatment used in HeartLight Ablation, is effective for treating atrial fibrillation, especially in patients with heart failure, with significant improvements in heart function and reduced recurrence of atrial fibrillation. Additionally, cryoablation is considered safe and effective, with advantages like shorter procedure times compared to other methods. ^{1 2 3 4 5}

Is HeartLight Ablation generally safe for humans?

Research on cryoballoon ablation, a similar procedure, shows it is generally safe for treating atrial fibrillation, with studies comparing its safety to other methods like radiofrequency ablation. ^{1 4 6 7 8}

How does the HeartLight Ablation treatment for atrial fibrillation differ from other treatments?

The HeartLight Ablation treatment is unique because it uses a laser-based system to visually guide the ablation process, which can offer more precision compared to traditional radiofrequency or cryoballoon ablation methods. This approach may improve the accuracy of targeting the heart tissue responsible for atrial fibrillation. ^{1 8 9 10 11}

Research Team

Eligibility Criteria

This trial is for adults over 18 who have atrial fibrillation, a type of irregular heartbeat. They should have tried at least one anti-arrhythmic drug that didn't work and are now planning to undergo catheter ablation because their heart condition causes symptoms.

Inclusion Criteria

I am 18 years old or older.

I have tried at least one medication for irregular heartbeats without success.

I am scheduled for a procedure to treat irregular heartbeats.

Exclusion Criteria

overall good health as established by multiple criteria

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Pulmonary vein isolation ablation with HeartLight Endoscopic Ablation System

Up to 90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Long-term follow-up

Assess relationship between operator experience and safety/effectiveness outcomes, including chronic safety and effectiveness

36 months

Treatment Details

Interventions

• Ablation (Ablation)
• HeartLight (Device)

Trial Overview The study is looking at the HeartLight System's performance in real-world medical use. It follows up on previous research by monitoring how well it works when doctors treat patients with this device after it has been approved for use.

Participant Groups

Group I: Treatment Experimental Treatment 2 Interventions

Pulmonary vein isolation ablation with HeartLight Endoscopic Ablation System

Ablation is already approved in Canada, Japan, China for the following indications:

Approved in Canada as Ablation Therapy for:

• Atrial Fibrillation
• Ventricular Tachycardia
• Other cardiac arrhythmias

Approved in Japan as Ablation Therapy for:

• Atrial Fibrillation
• Ventricular Tachycardia

Approved in China as Ablation Therapy for:

• Atrial Fibrillation
• Ventricular Tachycardia

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Illinois Chicago, IL

University Of Virginia Health System Charlottesville, VA

Mount Sinai Hospital New York, NY

University of Arizona Sarver HeartCenter Tucson, AZ

Who Is Running the Clinical Trial?

CardioFocus

Lead Sponsor

Trials

11

Patients Recruited

1,100+

Findings from Research

In a study of 122 patients undergoing cryoballoon ablation for atrial fibrillation, the POLARx system demonstrated superior cooling kinetics, achieving lower nadir temperatures and longer thawing times compared to the Arctic Front Advance Pro (AFAP) system.

Despite differences in cooling performance, both ablation systems showed comparable rates of atrial fibrillation recurrence after one year, indicating similar efficacy and safety profiles regardless of pulmonary vein anatomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Procedural performance between two cryoballoon systems for ablation of atrial fibrillation depends on pulmonary vein anatomy. Menger, V., Frick, M., Sharif-Yakan, A., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Surgical treatment of atrial fibrillation using argon-based cryoablation during concomitant cardiac procedures. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Catheter ablation improves outcomes and quality of life in Japanese patients with early-stage atrial fibrillation: A retrospective cohort study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Long-term outcomes of index cryoballoon ablation or point-by-point radiofrequency ablation in patients with atrial fibrillation and systolic heart failure. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

Procedural performance between two cryoballoon systems for ablation of atrial fibrillation depends on pulmonary vein anatomy. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Outcomes Of Cryoballoon Ablation Of Atrial Fibrillation: A Comprehensive Review. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

Adverse events in cryoballoon ablation for pulmonary vein isolation: Insight from the Food and Drug Administration Manufacturer and User Facility Device Experience. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Is the time between first diagnosis of paroxysmal atrial fibrillation and cryoballoon ablation a predictor of efficacy? [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Is cryoballoon ablation preferable to radiofrequency ablation for treatment of atrial fibrillation by pulmonary vein isolation? A meta-analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

German ablation registry: Cryoballoon vs. radiofrequency ablation in paroxysmal atrial fibrillation--One-year outcome data. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Cryoballoon versus RF ablation in paroxysmal atrial fibrillation: results from the German Ablation Registry. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Pulmonary vein reconnection following catheter ablation of atrial fibrillation using the second-generation cryoballoon versus open-irrigated radiofrequency: results of a multicenter analysis. [2018]