STOP Persistent AF PAS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-19

Study Completion Date

2028-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Persistent Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Arctic Front™ Cardiac Cryoablation Catheter System

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Khaldoun Tarakji, MD

Role: STUDY_DIRECTOR

Medtronic CAS Chief Medical Officer

Locations

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Hartford Hospital

Hartford, Connecticut, United States

Site Status

Cardiology Associates of Fairfield County

Stamford, Connecticut, United States

Site Status

BayCare Medical Group Cardiology

Clearwater, Florida, United States

Site Status

Heart Rhythms Solutions

Davie, Florida, United States

Site Status

Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

Henry Ford Heart & Vascular

Detroit, Michigan, United States

Site Status

Spectrum Health Hospitals

Grand Rapids, Michigan, United States

Site Status

The Lindner Research Center

Cincinnati, Ohio, United States

Site Status

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Site Status

Texas Health Research & Education Institute

Dallas, Texas, United States

Site Status

Kepler Universitätsklinikum Med Campus III.

Linz, , Austria

Site Status

St. Vinzenz-Hospital Köln

Cologne, , Germany

Site Status

MVZ CCB Frankfurt und Main Taunus

Frankfurt am Main, , Germany

Site Status

Städtische Kliniken München GmbH - Klinikum Bogenhausen

München, , Germany

Site Status

Universitaria Pisana - Stabilimento di Cisanello

Pisa, , Italy

Site Status

Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodz

Lodz, , Poland

Site Status

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, , United Kingdom

Site Status

Countries

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United States Austria Germany Italy Poland United Kingdom

Other Identifiers

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