RecruitingNCT05227053

STOP AF First Post-Approval Study

STOP AF First Post-Approval Study, an Addendum to the Cryo Global Registry


Sponsor

Medtronic Cardiac Ablation Solutions

Enrollment

200 participants

Start Date

Apr 28, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

The STOP AF First PAS is a prospective, global, multi-center, observational trial.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This post-approval study is following patients who undergo a heart procedure called cryoablation — which uses freezing to destroy abnormal electrical tissue causing atrial fibrillation (AFib), an irregular heartbeat. It is collecting real-world safety and effectiveness data after the device received approval. **You may be eligible if...** - You are 18 or older - You have been diagnosed with symptomatic paroxysmal AFib (AFib that comes and goes with symptoms) - You are planning to have a pulmonary vein isolation procedure using the Arctic Front cryoablation catheter system - You are willing to complete follow-up visits **You may NOT be eligible if...** - You have persistent or permanent AFib (not the intermittent type) - You have had a prior AFib ablation procedure - You have serious structural heart disease - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEArctic Front™ Cardiac Cryoablation Catheter

Pulmonary vein isolation will be performed with the Arctic Front™ cardiac cryoablation catheter system


Locations(13)

Alaska Heart Institute

Anchorage, Alaska, United States

Cardiology Associates of Fairfield County

Stamford, Connecticut, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

BayCare Medical Group Cardiology

Clearwater, Florida, United States

Heart Rhythm Solutions

Davie, Florida, United States

Iowa Heart

West Des Moines, Iowa, United States

Our Lady of the Lake

Baton Rouge, Louisiana, United States

Southcoast Health System

North Dartmouth, Massachusetts, United States

Henry Ford Heart & Vascular

Detroit, Michigan, United States

The Lindner Research Center

Cincinnati, Ohio, United States

Stern Cardiovascular Foundation

Germantown, Tennessee, United States

University of Tennessee Methodist Physicians

Memphis, Tennessee, United States

Texas Health Research and Education Institute

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05227053


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