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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STOP Persistent AF Post-Approval Study, a Sub-study to the Cryo Global Registry
- ClinicalTrials.gov ID
- NCT05005949
- Acronym / sponsor ID
- STOP Persistent AF PAS
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 393 participants (actual)
- Lead sponsor
- Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The STOP Persistent AF Post Approval Study (PAS) is a prospective, global, multicenter, observational trial.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arctic Front™ Cardiac Cryoablation Catheter SystemPulmonary vein isolation will be performed with the Arctic Front™ Cardiac Cryoablation Catheter System | Device | – |
Primary outcome
Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT)
Time frame: 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
Time frame: 12 months
Estimate primary safety Adverse Event (AE) rates for cryoablation using the Arctic Front™ Cardiac Cryoablation Catheter System through 12-months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaldoun Tarakji, MD study director
Medtronic CAS Chief Medical Officer
17 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 17 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Germany, Austria, Italy, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT) (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.