STOP Persistent AF PAS

Persistent Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05005949
• Other study ID #: STOP Persistent AF PAS
• Status: Recruiting
• Start date: August 19, 2021
• Est. completion date: August 2027

Study information

• Verified date: April 2024
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: Ryan Radtke
• Phone: 712.941.9372
• Email: ryan.s.radtke[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 2027
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Italy,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36 months
Primary	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.	12 months