Paroxysmal Atrial FibrillationNCT05227053
STOP AF First Post-Approval Study
An observational study of Paroxysmal Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 11 sites in United States.
Trial summary
The STOP AF First PAS is a prospective, global, multi-center, observational trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Arctic Front™ Cardiac Cryoablation Catheter
- Type of treatment
- Medical device
- How many people
- 142 participants
- Where
- 11 sitesUnited States
- Study dates
- 28 Apr 2022to 18 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Alaska Heart Institute
Anchorage, Alaska, 99508
The Lindner Research Center
Cincinnati, Ohio, 45219
BayCare Medical Group Cardiology
Clearwater, Florida, 33756
Texas Health Research and Education Institute
Dallas, Texas, 75231
Heart Rhythm Solutions
Davie, Florida, 33328
Henry Ford Heart & Vascular
Detroit, Michigan, 48202-2608
Stern Cardiovascular Foundation
Germantown, Tennessee, 38138
Southcoast Health System
North Dartmouth, Massachusetts, 02747
Cardiology Associates of Fairfield County
Stamford, Connecticut, 06905-5522
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Iowa Heart
West Des Moines, Iowa, 50266
About this study
Official title: STOP AF First Post-Approval Study, an Addendum to the Cryo Global Registry
The STOP AF First PAS is a prospective, global, multi-center, observational trial.
Read the 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.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Arctic Front™ Cardiac Cryoablation Catheter
- 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 CatheterDevice
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 posted7 Feb 2022
- Study start28 Apr 2022
- Primary completion18 Sep 2026
- Study completion18 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal 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
- 142 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
- NCT05227053
- Sponsor's protocol ID
- STOP AF First PAS
- Status last verified
- Oct 2026
- First submitted
- 27 Jan 2022
- Last updated
- 23 Oct 2026
- Results posted
- 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 AF First Post-Approval Study, an Addendum to the Cryo Global Registry
- ClinicalTrials.gov ID
- NCT05227053
- Acronym / sponsor ID
- STOP AF First PAS
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 18 Sep 2026 (actual)
- Study completion
- 18 Sep 2026 (actual)
- First posted
- 7 Feb 2022 (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 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.
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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- History of AF treatment with a class I or III antiarrhythmic drug, including sotalol, with the intention to prevent an AF recurrence1
- 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.
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 CatheterPulmonary 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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paroxysmal Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 11 sites in United States.
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 8 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: finished, 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 11 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.