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Procedure

Cryoablation for Atrial Fibrillation

N/A
Recruiting
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Known or pre-existing severe PV Stenosis
Any prior LA ablation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

This trial aims to gather information on how safe and effective Boston Scientific's Cardiac Cryoablation System is when used to treat Atrial Fibrillation by isolating pulmonary veins.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort or bruising at the catheter insertion site, heart rhythm problems during or after the procedure, throat irritation if a breathing tube was used, and rarely more serious complications like blood vessel damage.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a severe narrowing of the pulmonary valve in my heart.
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I have had a previous LA ablation procedure.
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I cannot or do not want to attend all required study visits.
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I have severe valve disease or a mechanical/biological heart valve replacement.
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I currently have an active infection.
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I have no health conditions that prevent me from having AF ablation or taking blood thinners.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Freedom From Primary Safety Events at 12 Months Post-procedure (Acute and Chronic Events) Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models
Percentage of Participants With Freedom From Treatment Failure at 12 Months Post-procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models

Trial Design

1Treatment groups
Experimental Treatment
Group I: CryoablationExperimental Treatment1 Intervention
Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Boston Scientific Cardiac Cryoablation System
2020
N/A
~860

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
737 Previous Clinical Trials
854,036 Total Patients Enrolled
75 Trials studying Atrial Fibrillation
31,827 Patients Enrolled for Atrial Fibrillation
Wilber W Su, MD,FACC,FHRSStudy ChairBanner- University Medical Group- Heart Center, Phoenix, AZ, USA
1 Previous Clinical Trials
458 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
458 Patients Enrolled for Atrial Fibrillation
~133 spots leftby May 2026
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