Cryoablation for Atrial Fibrillation

Recruiting at 7 trial locations

Overseen By Sharon Mensah

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Disqualifiers: Severe valvular disease, Prosthetic heart valve, Severe PV stenosis, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment for atrial fibrillation (AF), a condition where the heart beats irregularly. The treatment uses Boston Scientific's Cardiac Cryoablation System to freeze and isolate the pulmonary veins in the heart, potentially stopping irregular heartbeats. People with AF who haven’t found success with medication and experience symptoms might be suitable for this study. Participants must attend all study visits and follow the trial procedures. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for AF.

Will I have to stop taking my current medications?

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

What prior data suggests that the Boston Scientific Cardiac Cryoablation System is safe for pulmonary vein isolation in atrial fibrillation?

Research has shown that the Boston Scientific Cardiac Cryoablation System is generally well-tolerated. One study found that 96% of patients experienced no major safety issues after 12 months, with some groups faring even better. This indicates that most people do not encounter serious problems with the treatment. Although some risks exist, evidence suggests the system is safe for many patients treated for atrial fibrillation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for atrial fibrillation, which often involve radiofrequency ablation or antiarrhythmic drugs, the Boston Scientific Cardiac Cryoablation System uses extreme cold to target and destroy heart tissue causing irregular heartbeats. This cryoablation technique potentially offers a more precise and controlled method of ablation, which might reduce the risk of damaging surrounding tissues. Researchers are excited about this approach because it could lead to quicker recovery times and fewer complications, making it an appealing alternative for patients with atrial fibrillation.

What evidence suggests that the Boston Scientific Cardiac Cryoablation System is effective for atrial fibrillation?

Research has shown that the Boston Scientific Cardiac Cryoablation System, used by participants in this trial, effectively treats atrial fibrillation (AF), a condition causing irregular heartbeats. Studies found that 79.9% of patients remained free from AF symptoms 12 months after using this system. The system targets and isolates the pulmonary veins, helping to stop the irregular heartbeats. It also maintains a high safety record, with 96.0% of patients avoiding major complications. Overall, this treatment manages AF symptoms safely and effectively. ^{1 2 6 7 8}

Who Is on the Research Team?

Wilber W Su, MD,FACC,FHRS

Principal Investigator

Banner- University Medical Group- Heart Center, Phoenix, AZ, USA

Are You a Good Fit for This Trial?

This trial is for individuals who have recurrent, symptomatic paroxysmal atrial fibrillation that hasn't improved with medication. Participants must be able to give informed consent and commit to all required testing at an approved study center.

Inclusion Criteria

My doctor recommends cryoablation for my persistent atrial fibrillation.

I am willing and able to attend all study-related tests at the approved center.

I am willing and able to give my consent for treatment.

Exclusion Criteria

I have a severe narrowing of the pulmonary valve in my heart.

I have had a previous LA ablation procedure.

I cannot or do not want to attend all required study visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on freedom from treatment failure and primary safety events

12 months

Regular follow-up visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

• Boston Scientific Cardiac Cryoablation System

Trial Overview The safety, effectiveness, and procedural success of the Boston Scientific Cardiac Cryoablation System are being evaluated. This system is used for pulmonary vein isolation in patients with new-onset atrial fibrillation.

How Is the Trial Designed?

Group I: Cryoablation Experimental Treatment 1 Intervention

Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System.

Boston Scientific Cardiac Cryoablation System is already approved in European Union, United States, Japan, Canada for the following indications:

Approved in European Union as POLARx Cryoablation System for:

• Paroxysmal Atrial Fibrillation (AF)

Approved in United States as POLARx Cryoablation System for:

• Paroxysmal Atrial Fibrillation (AF)

Approved in Japan as POLARx Cryoablation System for:

• Paroxysmal Atrial Fibrillation (AF)

Approved in Canada as POLARx Cryoablation System for:

• Paroxysmal Atrial Fibrillation (AF)

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Published Research Related to This Trial

The new PolaRx cryoballoon from Boston Scientific represents an advancement in atrial fibrillation ablation, offering unique features that may enhance treatment success and safety compared to the Medtronic Arctic Front Advance system.

Further large-scale trials and clinical experience are necessary to fully compare the effectiveness and safety of the PolaRx cryoballoon with existing options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A second cryoballoon system-New and improved? Su, WW.[2021]

The POLARx cryoballoon catheter is effective for pulmonary vein isolation in patients with atrial fibrillation, showing similar procedural times and low complication rates compared to the Arctic Front Advance catheter, based on a study of 40 cases for each device.

While the POLARx catheter achieved effective isolation with lower nadir and balloon temperatures, further studies are needed to confirm its efficacy equivalence to the Arctic Front Advance, especially regarding optimal dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First experience of POLARx™ versus Arctic Front Advance™: An early technology comparison. Creta, A., Kanthasamy, V., Schilling, RJ., et al.[2021]

The POLARx cryoballoon system achieved a high rate of acute isolation of pulmonary veins (99.5%) comparable to the AFA-Pro system (100%), indicating its efficacy in treating atrial fibrillation.

POLARx demonstrated faster cooling rates and lower balloon temperatures during the procedure, although the total procedure time was longer initially; however, this time improved after a learning curve, suggesting it is a viable option for cryoballoon ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of procedural efficacy and biophysical parameters between two competing cryoballoon technologies for pulmonary vein isolation: Insights from an initial multicenter experience. Yap, SC., Anic, A., Breskovic, T., et al.[2021]

In a study of 596 patients undergoing cryoballoon-guided pulmonary vein isolation for atrial fibrillation, the novel POLARx system achieved lower nadir temperatures and a higher success rate for isolating pulmonary veins on the first freeze compared to the established Arctic Front Advance system.

While both systems demonstrated comparable safety and efficacy, the POLARx system resulted in longer procedure and fluoroscopy times, with one major complication in the POLARx group and three in the Arctic Front Advance group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

News from the Cold Chamber: Clinical Experiences of POLARx versus Arctic Front Advance for Single-Shot Pulmonary Vein Isolation. Guckel, D., Lucas, P., Isgandarova, K., et al.[2022]

In a comparison of two cryoballoon systems for catheter ablation of atrial fibrillation, POLARx and AFA-Pro showed similar procedural efficacy in 310 patients, meaning both were equally effective in achieving pulmonary vein isolation.

The POLARx system achieved lower balloon nadir temperatures during the procedure, which could enhance its effectiveness, but the risk of phrenic nerve palsy remained similar between the two systems, indicating comparable safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of procedural efficacy, balloon nadir temperature, and incidence of phrenic nerve palsy between two cryoballoon technologies for pulmonary vein isolation: A systematic review and meta-analysis. Assaf, A., Bhagwandien, R., Szili-Torok, T., et al.[2022]

The Polarx™ cryoablation system demonstrated similar efficacy to the Arctic Front™ cryoballoon in achieving pulmonary vein occlusion and electrical isolation in patients with atrial fibrillation, with 100% success in both systems.

Patients treated with Polarx™ experienced significantly shorter procedure and fluoroscopy times, as well as lower cumulative freeze duration, indicating a potentially more efficient treatment option for atrial fibrillation ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Procedural Safety and Efficacy for Pulmonary Vein Isolation with the Novel Polarx™ Cryoablation System: A Propensity Score Matched Comparison with the Arctic Front™ Cryoballoon in the Setting of Paroxysmal Atrial Fibrillation. Mojica, J., Lipartiti, F., Al Housari, M., et al.[2022]

The POLARx cryoballoon catheter, recently approved for use in Europe, features design improvements that enhance its ability to maintain balloon size and pressure during procedures.

These enhancements are expected to improve occlusion rates and potentially lead to better procedural outcomes for patients undergoing treatment for atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A tale of two balloons: technical and procedural difference between cryoballoon systems. Tomaiko-Clark, E., Bai, R., Khokhar, M., et al.[2023]

Citations

1. bostonscientific.com bostonscientific.com/en-US/products/catheters--ablation/polarx/clinical-evidence.html

Clinical evidence - POLARx Cryoablation System At 12 months, data revealed a 96.0%† freedom from primary safety events (100% for the POLARx™ FIT 12-month extension arm study) and a 79.9% freedom from atrial ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/P220032B.pdf

Summary of Safety and Effectiveness Data (SSED) Console. The Boston Scientific Cardiac Cryoablation System is intended for cryoablation and electrical mapping of the pulmonary veins for pulmonary vein ...

3. bostonscientific.com bostonscientific.com/en-EU/medical-specialties/electrophysiology/arrhythmias/single-shot-ablation/clinical-evidence.html

POLARx Clinical Evidence Numerous studies have demonstrated the safety and efficacy of the POLARx™ Cryoablation System in the treatment of paroxysmal atrial fibrillation. It has ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12017263/

Cryoballoon Ablation With the POLARx FIT or the Arctic ... Conclusion: The POLARx FIT™ CB-A was associated with a shorter procedure time, translating into lower procedural costs, compared with the Arctic ...

5. bostonscientific.com bostonscientific.com/content/dam/bostonscientific/ep/portfolio-group/single-shot/clinical-proof/EP-1576508-AC_POLARx-FROzEN-Data-Summary-Sheet-EU.pdf

FROzEN-AF US IDE Clinical Trial Results Evaluate the safety and effectiveness of the Boston Scientific POLARx™ Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal ...

6. bostonscientific.com bostonscientific.com/en-US/products/catheters--ablation/polarx/polarx-indications.html

POLARx™ Indications, Safety & Warnings The POLARx FIT Cryoablation Balloon Catheter is a single use, flexible, over-the-wire balloon catheter intended to ablate cardiac tissue.

7. bostonscientific.com bostonscientific.com/content/dam/bostonscientific/ep/Electrophysiology%20Portfolio/polarx/polarx-product-page/polarx-clinical-compendium.pdf

Clinical Compendium POLARxTM FIT Cryoablation Balloon Catheter INTENDED USE The Boston Scientific Cardiac Cryoablation System is intended for cryoablation and electrical ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04133168

NCT04133168 | Boston Scientific's Cryoballoon in the ... Multi-center, open label, prospective, single arm study to document the safety and performance of Boston Scientific's Cryoablation System. The Cryoablation ...