Clinical trial NCT05005949: STOP Persistent AF PAS
Official title: STOP Persistent AF Post-Approval Study, a Sub-study to the Cryo Global Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Persistent Atrial Fibrillation
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2021-08-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects ≥ 18 years of age (or minimum age as required by local regulations) who have a recommendation for a pulmonary vein ablation with the Arctic Front™ Cardiac Cryoablation Catheter System may be approached regarding enrollment in this study.

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

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT)
timeFrame: 36 months
measure: Freedom from Primary Safety Events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Stamford
country: United States
facility: Cardiology Associates of Fairfield County
state: Connecticut
city: Clearwater
country: United States
facility: BayCare Medical Group Cardiology
state: Florida
city: Davie
country: United States
facility: Heart Rhythms Solutions
state: Florida
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Heart & Vascular
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
city: Cincinnati
country: United States
facility: The Lindner Research Center
state: Ohio
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Dallas
country: United States
facility: Texas Health Research & Education Institute
state: Texas
city: Linz
country: Austria
facility: Kepler Universitätsklinikum Med Campus III.
city: Frankfurt am Main
country: Germany
facility: MVZ CCB Frankfurt und Main Taunus
city: Köln
country: Germany
facility: St. Vinzenz-Hospital Köln
city: München
country: Germany
facility: Städtische Kliniken München GmbH - Klinikum Bogenhausen
city: Pisa
country: Italy
facility: Universitaria Pisana - Stabilimento di Cisanello
city: Łódź
country: Poland
facility: Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodz
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital NHS Foundation Trust
Study officials:
affiliation: Medtronic CAS Chief Medical Officer
name: Khaldoun Tarakji, MD
role: STUDY_DIRECTOR
References: