Evaluating the safety and effectiveness of a cryoablation system for treating paroxysmal atrial fibrillation

Prospective Multi-Site Safety and Effectiveness Study of the Boston Scientific Cardiac Cryoablation System for Drug Refractory, Recurrent Symptomatic Paroxysmal Atrial Fibrillation

This study is testing a new cryoablation system to see if it can safely help people with recurring atrial fibrillation that hasn't improved with medication.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Boston Scientific Corporation (Industry-sponsored)
• Locations: 11 sites (Gilbert, Arizona and 10 other locations)
• Trial ID: NCT06170606 on ClinicalTrials.gov

What this trial studies

This study aims to collect clinical data on the safety, effectiveness, and procedural success of Boston Scientific's Cardiac Cryoablation System in performing pulmonary vein isolation for patients with de novo paroxysmal atrial fibrillation. Participants will be those who have recurrent symptomatic atrial fibrillation that is resistant to drug treatment. The study will involve monitoring outcomes related to the ablation procedure and patient health over time. The research will take place at several approved clinical investigational centers in Arizona.

Who should consider this trial

Good fit: Ideal candidates are individuals with drug-refractory, recurrent symptomatic paroxysmal atrial fibrillation who are eligible for cryoablation treatment.

Not a fit: Patients with contraindications to atrial fibrillation ablation or those who have had prior left atrial ablation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from recurrent paroxysmal atrial fibrillation.

How similar studies have performed: Previous studies using cryoablation for atrial fibrillation have shown promising results, indicating that this approach is both effective and safe.

Eligibility criteria

Inclusion Criteria:

* Subjects indicated for drug refractory, recurrent symptomatic PAF treatment with the Cryoablation System, per physician's medical judgement, and as per standard of care
* Subjects who are willing and capable of providing informed consent;
* Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center;

Exclusion Criteria:

* Any known contraindication to an AF ablation or anticoagulation, including those listed in the IFU as legally approved conditions;
* Any prior LA ablation;
* Known or pre-existing severe PV Stenosis;
* Subjects with severe valvular disease OR with a prosthetic - mechanical or biological - heart valve (not including valve repair and annular rings);
* Presence of any pulmonary vein stents;
* Subjects with active systemic infection;
* Subject is unable or not willing to complete follow-up visits and examination for the duration of the study;- Subjects with life expectancy ≤ 1 year per investigator's medical judgement;
* Women of childbearing potential who are, or plan to become, pregnant during the time of the study (assessment per investigator's discretion);

Where this trial is running

Gilbert, Arizona and 10 other locations

• Mercy Gilbert Medical Center — Gilbert, Arizona, United States (Recruiting)
• Banner University Medical Center Phoenix — Phoenix, Arizona, United States (Recruiting)
• Pima Heart & Vascular Clinical Research — Tucson, Arizona, United States (Withdrawn)
• Torrance Memorial Medical Center — Torrance, California, United States (Recruiting)
• Intermountain Platte Valley Hospital — Brighton, Colorado, United States (Active_not_recruiting)
• Valley View Hospital — Glenwood Springs, Colorado, United States (Recruiting)
• St. Joseph's Hospital/BayCare Medical Group — Tampa, Florida, United States (Recruiting)
• Bethesda North Hospital — Cincinnati, Ohio, United States (Recruiting)
• Prisma Health Richland Hospital — Columbia, South Carolina, United States (Recruiting)
• University of Texas Medical Branch - Galveston — Galveston, Texas, United States (Recruiting)
• Aurora Health — Grafton, Wisconsin, United States (Recruiting)

Study contacts

• Study coordinator: Sharon Mensah

Conditions Paroxysmal Atrial Fibrillation; Cryoablation