STOP Persistent AF PAS

NCT05005949 · tracked via the Priya Life Science Germany tracker

Sponsor

Medtronic Cardiac Ablation Solutions

Phase

Observational

Started

2021-08-19

Last updated

2026-07-22

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

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)

Facility	City	Region
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

Other trials for the same condition

VOLT CE Mark Study Active, not recruiting

A Prospective Clinical Study to Evaluate the Safety and Effectiveness of Pulmonary Vein Isolation Plus Box Isolation of Fibrotic Areas With the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation Recruiting

Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation Active, not recruiting

Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas Active, not recruiting

Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation 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 Germany