STOP Persistent AF PAS

N/AActive Not RecruitingNCT05005949

Medtronic Cardiac Ablation Solutions400 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Persistent Atrial Fibrillation

Interventions

Arctic Front™ Cardiac Cryoablation Catheter SystemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (17)

Hartford Hospital

Hartford, Connecticut, United States

Cardiology Associates of Fairfield County

Stamford, Connecticut, United States

Outcomes

Primary Outcomes

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.

Time frame: 36 months

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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