STOP AF First Post-Approval Study
- Conditions
- Paroxysmal Atrial Fibrillation
- Registration Number
- NCT05227053
- Lead Sponsor
- Medtronic Cardiac Ablation Solutions
- Brief Summary
The STOP AF First PAS is a prospective, global, multi-center, observational trial.
- Detailed Description
The STOP AF First Post Approval Study (PAS) is a sub-study to the Cryo Global Registry. The STOP AF First PAS is a prospective, global, multi-center, observational trial. The purpose of the study is to describe long-term clinical performance and safety data in the recurrent symptomatic paroxysmal AF population treated with Arctic Front™ and Freezor™ MAX Families of cardiac cryoablation catheters (hereafter referred to as Arctic Front™ Cardiac Cryoablation Catheter System) as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy. This PAS is a condition of the pre-market approval order (P100010/S110) by the U.S. Food and Drug Administration.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
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:
-
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)
-
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
-
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT) 36 months Estimate the 36-month freedom from Atrial Fibrillation (AF) /atrial flutter (AFL) /Atrial Tachycardia (AT) recurrence using the Arctic Front™ cardiac cryoablation catheter System.
Freedom from Primary Safety Events 12 months Estimate primary safety Adverse Event (AE) rates for cryoablation using the Arctic Front™ cardiac cryoablation catheter System through 12-months.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Alaska Heart Institute
🇺🇸Anchorage, Alaska, United States
Cardiology Associates of Fairfield County
🇺🇸Stamford, Connecticut, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
BayCare Medical Group Cardiology
🇺🇸Clearwater, Florida, United States
Heart Rhythm Solutions
🇺🇸Davie, Florida, United States
Iowa Heart
🇺🇸West Des Moines, Iowa, United States
Our Lady of the Lake
🇺🇸Baton Rouge, Louisiana, United States
Southcoast Health System
🇺🇸North Dartmouth, Massachusetts, United States
Henry Ford Heart & Vascular
🇺🇸Detroit, Michigan, United States
The Lindner Research Center
🇺🇸Cincinnati, Ohio, United States
Stern Cardiovascular Foundation
🇺🇸Germantown, Tennessee, United States
University of Tennessee Methodist Physicians
🇺🇸Memphis, Tennessee, United States
Texas Health Research and Education Institute
🇺🇸Dallas, Texas, United States