HeartLight Ablation for Atrial Fibrillation

Recruiting at 3 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CardioFocus

Must be taking: Anti-arrhythmics

Disqualifiers: Good health, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 90 days

250 Participants Needed

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}

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

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
• HeartLight

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 European Union, United States, Canada, Japan, China for the following indications:

Approved in European Union as Ablation Therapy for:

• Atrial Fibrillation
• Ventricular Tachycardia
• Other cardiac arrhythmias

Approved in United States as Ablation Therapy for:

• Atrial Fibrillation
• Ventricular Tachycardia
• Other cardiac arrhythmias
• Cancer treatment (e.g., liver, lung, kidney)

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

Who Is Running the Clinical Trial?

CardioFocus

Lead Sponsor

Trials

11

Recruited

1,100+

Findings from Research

In a study of 63 patients undergoing cardiac procedures, argon-based cryoablation for atrial fibrillation (AF) was found to be safe and effective, achieving an 88.5% freedom from AF rate at 12 months.

The procedure had no in-hospital deaths or strokes, although 19% of patients required a permanent pacemaker post-surgery, indicating a generally positive safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical treatment of atrial fibrillation using argon-based cryoablation during concomitant cardiac procedures. Mack, CA., Milla, F., Ko, W., et al.[2013]

In a study of 3318 patients with early-stage atrial fibrillation, those who underwent catheter ablation had a significantly lower risk of adverse clinical outcomes, including death, stroke, and heart failure hospitalization, compared to those receiving only medical therapy.

Catheter ablation also led to improved quality of life scores after one year, indicating that it not only reduces serious health risks but also enhances patients' overall well-being.

NCBI (Pubmed)

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. Seki, Y., Fujisawa, T., Ikemura, N., et al.[2022]

Cryoablation is an effective first-line treatment for atrial fibrillation in patients with heart failure, showing a 43% success rate in preventing AF recurrence, which increases to 59% after a repeat procedure.

Patients undergoing cryoablation experienced significant improvements in left ventricular ejection fraction (LVEF) and overall functional status, with results comparable to those receiving radiofrequency ablation.

NCBI (Pubmed)

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. Prabhu, S., Ahluwalia, N., Tyebally, SM., et al.[2022]

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]

Cryoballoon ablation is a safe and effective alternative to traditional radiofrequency ablation for treating symptomatic atrial fibrillation, showing comparable results in both short-term and long-term outcomes.

The newer second-generation cryoballoon technology has significantly improved the effectiveness of cryoablation, while also offering advantages like a gentler learning curve and shorter procedure times compared to radiofrequency ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes Of Cryoballoon Ablation Of Atrial Fibrillation: A Comprehensive Review. Aryana, A., Bowers, MR., O'Neill, PG.[2022]

In a review of 320 adverse events related to cryoballoon catheter use for pulmonary vein isolation over 10.7 years, the most common issue was phrenic nerve palsy, occurring in 48% of cases, followed by cardiac perforation at 15%.

All reported intra-procedural deaths were linked to cardiac perforation, highlighting a significant safety concern associated with this procedure.

NCBI (Pubmed)

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. Tan, MC., Tan, JL., Lee, WJ., et al.[2023]

In a study of 510 patients with drug-refractory paroxysmal atrial fibrillation, early cryoablation (within 15 months of diagnosis) significantly reduced the risk of atrial fibrillation recurrence compared to later treatment (more than 15 months after diagnosis).

Cryoablation was found to be safe and well-tolerated, with only 22 reported complications across all patients, indicating that the timing of the procedure does not affect its safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is the time between first diagnosis of paroxysmal atrial fibrillation and cryoballoon ablation a predictor of efficacy? Lunati, M., Arena, G., Iacopino, S., et al.[2019]

Cryoballoon ablation significantly reduces fluoroscopic time and total procedure time compared to radiofrequency ablation, with reductions of approximately 14.13 minutes and 29.65 minutes, respectively, based on a meta-analysis of 14 clinical trials involving 1,104 patients.

While the success rates for cryoballoon and radiofrequency ablation were similar, cryoballoon ablation was associated with a lower risk of recurrent atrial fibrillation and major complications, suggesting it may be a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is cryoballoon ablation preferable to radiofrequency ablation for treatment of atrial fibrillation by pulmonary vein isolation? A meta-analysis. Xu, J., Huang, Y., Cai, H., et al.[2022]

In a study of 2306 patients with paroxysmal atrial fibrillation, the recurrence rates of AF after one year were similar for both cryoballoon and radiofrequency ablation, at approximately 45%.

However, cryoballoon ablation was associated with a higher incidence of persistent phrenic nerve palsy (1.1%) compared to radiofrequency ablation (0.3%), indicating different safety profiles for the two methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

German ablation registry: Cryoballoon vs. radiofrequency ablation in paroxysmal atrial fibrillation--One-year outcome data. Schmidt, M., Dorwarth, U., Andresen, D., et al.[2016]

In a study of 3,775 patients with symptomatic paroxysmal atrial fibrillation, both cryoballoon and radiofrequency (RF) ablation showed similar acute success rates (97.5% for cryoballoon vs 97.6% for RF), indicating both methods are effective for this treatment.

While the overall complication rates were similar for both techniques (4.6% for each), cryoballoon ablation had a higher incidence of phrenic nerve palsy (2.1% vs 0.0% for RF), suggesting a need for careful monitoring when using cryoballoon technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoballoon versus RF ablation in paroxysmal atrial fibrillation: results from the German Ablation Registry. Schmidt, M., Dorwarth, U., Andresen, D., et al.[2022]

In a study of 2002 patients, catheter ablation of atrial fibrillation using the second-generation cryoballoon showed better long-term durability of pulmonary vein isolation compared to radiofrequency ablation, with fewer patients requiring repeat procedures (16.5% vs. 19.9%).

The cryoballoon method resulted in a lower incidence of atrial flutters/tachycardias (19.9% vs. 32.8%) and fewer instances of pulmonary vein reconnection (47.3% vs. 60.9%), indicating its greater efficacy in maintaining successful ablation outcomes.

NCBI (Pubmed)

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. Aryana, A., Singh, SM., Mugnai, G., et al.[2018]

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]