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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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