Long-term performance of cryoablation for paroxysmal atrial fibrillation

STOP AF First Post-Approval Study, an Addendum to the Cryo Global Registry

This study is testing how well a special freezing treatment works for people with recurring episodes of atrial fibrillation and whether it is safe over the long term.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Medtronic Cardiac Ablation Solutions (Industry-sponsored)
• Locations: 13 sites (Anchorage, Alaska and 12 other locations)
• Trial ID: NCT05227053 on ClinicalTrials.gov

What this trial studies

The STOP AF First Post Approval Study is a global, multi-center observational trial aimed at evaluating the long-term clinical performance and safety of the Arctic Front™ Cardiac Cryoablation Catheter System in patients with recurrent symptomatic paroxysmal atrial fibrillation. This study serves as a sub-study to the Cryo Global Registry and focuses on patients who are treated with cryoablation as an alternative to antiarrhythmic drug therapy for rhythm control. Participants will be monitored for outcomes related to their treatment over an extended period, providing valuable data on the effectiveness of this intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with symptomatic paroxysmal atrial fibrillation who are scheduled for a pulmonary vein isolation procedure using the Arctic Front™ catheter.

Not a fit: Patients who have previously undergone treatment with class I or III antiarrhythmic drugs for AF prevention may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients with paroxysmal atrial fibrillation.

How similar studies have performed: Other studies have shown promising results with cryoablation techniques for atrial fibrillation, indicating that this approach is supported by prior successful outcomes.

Eligibility criteria

Inclusion Criteria:

* Subject has been diagnosed with symptomatic paroxysmal AF
* Subject is ≥ 18 years of age or minimum age as required by local regulations
* Planned pulmonary vein isolation (PVI) procedure using the commercially available Arctic Front™ cardiac cryoablation catheter System.
* Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements

Exclusion Criteria:

History of AF treatment with a class I or III antiarrhythmic drug, including sotalol, with the intention to prevent an AF recurrence1

. Subjects under the following conditions may be included in the study:

1. Temporary treatment with a class I or III AAD (treatment at a therapeutic dose for a period of \<4 weeks prior to the index PVI procedure)
2. Recent treatment with a class I or III AAD (within 6 months of the index PVI procedure) at a dose below therapeutic threshold according to the AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation
3. A subject who has received a chemical cardioversion may be included in the study. This includes a chemical cardioversion prior to enrollment and between enrollment and ablation.

   * Subject has had a prior atrial ablation (except for cavo-tricuspid isthmus (CTI) ablation for AFL)
   * Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
   * Subject with exclusion criteria required by local law

Where this trial is running

Anchorage, Alaska and 12 other locations

• Alaska Heart Institute — Anchorage, Alaska, United States (Active_not_recruiting)
• Cardiology Associates of Fairfield County — Stamford, Connecticut, United States (Recruiting)
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (Recruiting)
• BayCare Medical Group Cardiology — Clearwater, Florida, United States (Recruiting)
• Heart Rhythm Solutions — Davie, Florida, United States (Recruiting)
• Iowa Heart — West Des Moines, Iowa, United States (Recruiting)
• Our Lady of the Lake — Baton Rouge, Louisiana, United States (Recruiting)
• Southcoast Health System — North Dartmouth, Massachusetts, United States (Recruiting)
• Henry Ford Heart & Vascular — Detroit, Michigan, United States (Recruiting)
• The Lindner Research Center — Cincinnati, Ohio, United States (Recruiting)
• Stern Cardiovascular Foundation — Germantown, Tennessee, United States (Recruiting)
• University of Tennessee Methodist Physicians — Memphis, Tennessee, United States (Recruiting)
• Texas Health Research and Education Institute — Dallas, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Mary Sauline

Conditions Paroxysmal Atrial Fibrillation