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Clinical Trials in Poland / NCT05005949
Active, not recruiting Observational

STOP Persistent AF PAS

NCT05005949 · tracked via the Priya Life Science Poland tracker
Sponsor
Medtronic Cardiac Ablation Solutions
Phase
Observational
Started
2021-08-19
Last updated
2026-10-23

Condition(s) studied

Persistent Atrial Fibrillation

Investigational drug(s) / intervention(s)

Arctic Front™ Cardiac Cryoablation Catheter System

Arctic Front™ Cardiac Cryoablation Catheter System: Pulmonary vein isolation will be performed with the Arctic Front™ Cardiac Cryoablation Catheter System

Study summary

The STOP Persistent AF Post Approval Study (PAS) is a prospective, global, multicenter, observational trial.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (17)

FacilityCityRegionStatus
Hartford Hospital Hartford Connecticut
Cardiology Associates of Fairfield County Stamford Connecticut
BayCare Medical Group Cardiology Clearwater Florida
Heart Rhythms Solutions Davie Florida
Carle Foundation Hospital Urbana Illinois
Henry Ford Heart & Vascular Detroit Michigan
Spectrum Health Hospitals Grand Rapids Michigan
The Lindner Research Center Cincinnati Ohio
Texas Cardiac Arrhythmia Research Foundation Austin Texas
Texas Health Research & Education Institute Dallas Texas
Kepler Universitätsklinikum Med Campus III. Linz Austria
St. Vinzenz-Hospital Köln Cologne Germany
MVZ CCB Frankfurt und Main Taunus Frankfurt am Main Germany
Städtische Kliniken München GmbH - Klinikum Bogenhausen München Germany
Universitaria Pisana - Stabilimento di Cisanello Pisa Italy
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodz Lodz Poland
Liverpool Heart and Chest Hospital NHS Foundation Trust Liverpool United Kingdom

More Medtronic Cardiac Ablation Solutions trials in Poland

DiamondTemp Global Registry Active, not recruiting

Other trials for the same condition

Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration Recruiting
BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05005949 on ClinicalTrials.gov ↗ ← All trials in Poland