Cryoablation for Atrial Fibrillation

Recruiting at 9 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

Trial Summary

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 data supports the effectiveness of the treatment Boston Scientific Cardiac Cryoablation System for atrial fibrillation?

The POLARx cryoballoon system from Boston Scientific is shown to be comparable to the Arctic Front Advance Pro system, which is widely used for treating atrial fibrillation. The POLARx system maintains constant balloon pressure and is more compliant during freezing, which may enhance its effectiveness and safety. ^{1 2 3 4 5}

Is cryoablation for atrial fibrillation using the POLARx system safe?

The POLARx cryoablation system for treating atrial fibrillation is generally considered safe, with similar safety profiles to other systems like the Arctic Front Advance. In a study, major complications were rare, occurring in 2% of patients using POLARx and 1% using the other system. ^{1 2 4 5 6}

How is the POLARx Cryoablation System different from other treatments for atrial fibrillation?

The POLARx Cryoablation System is unique because it maintains a constant balloon pressure and is more compliant during freezing compared to other cryoballoon technologies, which may improve its effectiveness and safety in treating atrial fibrillation. ^{1 2 3 5 7}

What is the purpose of this trial?

To collect clinical data on safety, effectiveness and procedural success of Boston Scientific's Cardiac Cryoablation System (includes all BSC commercially available POLARx/POLARx Fit catheters) when used to perform pulmonary vein isolation (PVI) in the ablation treatment of de novo Atrial Fibrillation (AF).

Research Team

Wilber W Su, MD,FACC,FHRS

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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 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]

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]

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]

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]

References

1. United States 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. [2021]

2. United States 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. [2022]

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

A tale of two balloons: technical and procedural difference between cryoballoon systems. [2023]

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

A second cryoballoon system-New and improved? [2021]

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

First experience of POLARx™ versus Arctic Front Advance™: An early technology comparison. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

News from the Cold Chamber: Clinical Experiences of POLARx versus Arctic Front Advance for Single-Shot Pulmonary Vein Isolation. [2022]

7. United States 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. [2022]