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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the HeartLight System in treating atrial fibrillation (a heart rhythm problem) outside of a lab setting. The focus is on using ablation, a procedure to correct irregular heartbeats, by isolating the pulmonary veins. It builds on past studies to determine if results remain consistent in real-world settings. Suitable participants have tried at least one medication without success and continue to experience noticeable symptoms from atrial fibrillation. As an unphased trial, this study provides patients the opportunity to contribute to understanding the effectiveness of treatments in real-world conditions.

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 prior data suggests that the HeartLight System is safe for atrial fibrillation treatment?

Research has shown that the HeartLight Endoscopic Ablation System is generally safe for treating atrial fibrillation (AFib). In earlier studies, two deaths occurred, but the device did not cause them. There were also 14 serious side effects, including some cases of nerve damage and stroke, though these are rare.

Another study found that the system provides a quick and reliable method for treating AFib by isolating the pulmonary veins. Most patients tolerate the treatment well. Additionally, the FDA has approved the device, indicating it has passed thorough safety checks for treating AFib. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HeartLight Ablation System for treating atrial fibrillation because it offers a unique approach with its endoscopic technology. Unlike standard treatments like radiofrequency or cryoablation, HeartLight uses laser energy to isolate the pulmonary veins and potentially offers more precise targeting. This precision could lead to fewer complications and better long-term outcomes for patients. The ability to visually guide the ablation process is a game-changer, making the procedure potentially safer and more effective.

What is the effectiveness track record for the HeartLight Ablation System in treating atrial fibrillation?

Research has shown that the HeartLight Ablation system effectively treats atrial fibrillation, a common heart rhythm problem. One study found that 75% of patients using the HeartLight system were free from atrial fibrillation symptoms after 12 months. Another study reported excellent results at both 6 and 12 months, with many patients experiencing symptom relief. The system uses a precise laser to target the pulmonary veins, helping to stop irregular heartbeats. These findings suggest that HeartLight Ablation is a promising treatment for those dealing with atrial fibrillation. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

I am scheduled for a procedure to treat irregular heartbeats.

This criterion does not apply to my situation.

Exclusion Criteria

overall good health as established by multiple criteria

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.120.009544

Pivotal Study of a Novel Motor-Driven Endoscopic Ablation ... The 6-month and 12-month atrial fibrillation–free rates for X3 compare favorably with the rates reported for HeartLight, 89.5% versus 75.0% and ...

2. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_pas.cfm?t_id=679042&c_id=6084

Post-Approval Studies (PAS) Database - accessdata.fda.gov The primary effectiveness endpoint will be freedom from symptomatic Atrial Fibrillation at one-year, and will be compared to a performance goal of 55% of ...

3. prnewswire.com prnewswire.com/news-releases/cardiofocus-announces-the-publication-of-heartlight-x3-pivotal-study-data-301235152.html

CardioFocus Announces The Publication Of HeartLight X3 ... The HeartLight X3 system also showed improvement in chronic effectiveness at both 6 and 12 months. Freedom from symptomatic AFib reported at 6 ...

4. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(21)01547-2/fulltext

B-PO05-091 SAFETY AND EFFICACY OF CONTINUOUS ... The novel LB3 system with continuous laser ablation provides fast and safe PVI procedure for the treatment of paroxysmal and persistent AF patients.

5. citoday.com citoday.com/news/cardiofocus-begins-introduction-of-heartlight-x3-system-for-the-treatment-of-afib

CardioFocus Begins Introduction of HeartLight X3 System ... Approval was supported by data from a study of the HeartLight X3 in the treatment of 60 patients over 12 months. All study endpoints were ...

6. innovationsincrm.com innovationsincrm.com/latest-news/1368-cardiofocus-heartlight-x3-trial

CardioFocus Completes Enrollment in HeartLight® X3 Trial A total of 60 patients have been treated in this pivotal confirmatory trial with a one-month follow up. The trial will evaluate time, safety and acute outcomes ...

7. prnewswire.com prnewswire.com/news-releases/cardiofocus-announces-us-fda-approval-of-heartlight-x3-system-for-the-treatment-of-atrial-fibrillation-301057007.html

CardioFocus Announces US FDA Approval of HeartLight® ... "The HeartLight X3 System introduces a new level of speed, control and predictability for physicians - making it an ideal tool for AFib ablation ...

8. dicardiology.com dicardiology.com/content/cardiofocus-announces-pulsed-field-ablation-milestones

CardioFocus Announces Pulsed Field Ablation Milestones CardioFocus is leveraging the outstanding clinical performance of its flagship HeartLight X3 System to address the shortcomings of the currently ...