Persistent Atrial FibrillationNCT05005949
STOP Persistent AF PAS
An observational study of Persistent Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 17 sites in 6 countries.
Trial summary
The STOP Persistent AF Post Approval Study (PAS) is a prospective, global, multicenter, observational trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Arctic Front™ Cardiac Cryoablation Catheter System
- Type of treatment
- Medical device
- How many people
- 393 participants
- Where
- 17 sitesin 6 countries
- Study dates
- 19 Aug 2021to Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects ≥ 18 years of age (or minimum age as required by local regulations) who have a recommendation for a pulmonary vein ablation with the Arctic Front™ Cardiac Cryoablation Catheter System may be approached regarding enrollment in this study.
Who may be able to join
- Subject has been diagnosed with persistent AF.
- Subject is ≥ 18 years of age or minimum age as required by local regulations.
- Planned pulmonary vein isolation (PVI) procedure using 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 6 countries.
17 sites in 6 countries
United States10 sites
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705-1852
The Lindner Research Center
Cincinnati, Ohio, 45219-2906
BayCare Medical Group Cardiology
Clearwater, Florida, 33756
Texas Health Research & Education Institute
Dallas, Texas, 75231
Heart Rhythms Solutions
Davie, Florida, 33328
Henry Ford Heart & Vascular
Detroit, Michigan, 48202-2608
Spectrum Health Hospitals
Grand Rapids, Michigan, 49525-6427
Hartford Hospital
Hartford, Connecticut, 06102
Cardiology Associates of Fairfield County
Stamford, Connecticut, 06905-5522
Carle Foundation Hospital
Urbana, Illinois, 61801-2500
Germany3 sites
St. Vinzenz-Hospital Köln
Cologne, 50733
MVZ CCB Frankfurt und Main Taunus
Frankfurt am Main, 60431
Städtische Kliniken München GmbH - Klinikum Bogenhausen
München, 81925
Poland1 site
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodz
Lodz, 92-213
United Kingdom1 site
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, L14 3PE
About this study
Official title: STOP Persistent AF Post-Approval Study, a Sub-study to the Cryo Global Registry
The STOP Persistent AF Post Approval Study (PAS) is a prospective, global, multicenter, observational trial.
Read the detailed description
The STOP Persistent AF Post Approval Study (PAS) is a sub-study to the Cryo Global Registry. The PAS is a prospective, global, multicenter, observational trial. The purpose of the PAS is to describe long-term clinical performance and safety data in the Persistent AF population treated with Arctic Front™ and Freezor™ MAX Families of Cardiac Cryoablation Catheters (hereafter referred to as Arctic Front™ Cardiac Cryoablation Catheter System). This PAS is a condition of the Pre-Market Approval order (P100010/S098) by the U.S. Food and Drug Administration. Up to 400 subjects will be enrolled to ensure 355 are treated. A minimum of 50% of patients will be enrolled and treated in the US. The follow-up duration for this post-approval study will be 36-months.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Arctic Front™ Cardiac Cryoablation Catheter System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arctic Front™ Cardiac Cryoablation Catheter SystemDevice
Pulmonary vein isolation will be performed with the Arctic Front™ Cardiac Cryoablation Catheter System
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT)
Estimate the 36-month freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT) recurrence using the Arctic Front™ Cardiac Cryoablation Catheter System.
Measured: 36 months
Freedom from Primary Safety Events
Estimate primary safety Adverse Event (AE) rates for cryoablation using the Arctic Front™ Cardiac Cryoablation Catheter System through 12-months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start19 Aug 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 393 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Ablation Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Khaldoun Tarakji, MD, Study director, Medtronic CAS Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005949
- Sponsor's protocol ID
- STOP Persistent AF PAS
- Status last verified
- May 2026
- First submitted
- 29 Jul 2021
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes