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Observational study on long-term outcomes of cryoablation for persistent atrial fibrillation

STOP Persistent AF Post-Approval Study, a Sub-study to the Cryo Global Registry

Observational Medtronic Cardiac Ablation Solutions · NCT05005949

This study is testing how well a special freezing treatment for persistent atrial fibrillation works and how safe it is for patients over three years.

Quick facts

Study typeObservational
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorMedtronic Cardiac Ablation Solutions Industry-sponsored
Locations17 sites (Hartford, Connecticut and 16 other locations)
Trial IDNCT05005949 on ClinicalTrials.gov

What this trial studies

The STOP Persistent AF Post Approval Study is a global, multicenter observational trial aimed at assessing the long-term clinical performance and safety of the Arctic Front™ Cardiac Cryoablation Catheter System in patients with persistent atrial fibrillation. This study is a sub-study of the Cryo Global Registry and will enroll up to 400 subjects, with a minimum of 50% of participants treated in the United States. Participants will be followed for 36 months to gather comprehensive data on treatment outcomes. The study is conducted under the conditions set by the U.S. Food and Drug Administration as part of the device's pre-market approval.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with persistent atrial fibrillation and are scheduled for a pulmonary vein isolation procedure using the Arctic Front™ Cardiac Cryoablation Catheter System.

Not a fit: Patients who have previously undergone atrial ablation or are enrolled in other concurrent studies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of cryoablation for patients with persistent atrial fibrillation.

How similar studies have performed: Other studies involving cryoablation for atrial fibrillation have shown promising results, indicating that this approach has potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Hartford, Connecticut and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Persistent Atrial Fibrillation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.