RecruitingNot ApplicableNCT03546374

Medtronic Terminate AF Study

Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)


Sponsor

Medtronic Cardiac Surgery

Enrollment

160 participants

Start Date

Nov 15, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal atrial fibrillation (AF).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a surgical procedure to correct an abnormal heart rhythm (called non-paroxysmal atrial fibrillation, or persistent AF) done at the same time as open-heart surgery for another reason (like bypass or valve repair) can restore normal rhythm and reduce the need for blood thinners. **You may be eligible if...** - You have persistent or longstanding persistent atrial fibrillation (an irregular heartbeat that does not go away on its own) - You already need non-emergency open-heart surgery for another reason, such as bypass surgery or a heart valve procedure - You are able to take blood-thinning medications (warfarin or NOACs) **You may NOT be eligible if...** - You have Wolff-Parkinson-White syndrome (an abnormal electrical pathway in the heart) - Your heart failure is in the most severe category (NYHA Class IV) - Your heart's pumping strength is severely reduced (ejection fraction 30% or below) - You need emergency heart surgery - You have previously had AF ablation, AV node ablation, or a surgical Maze procedure - You cannot take blood-thinning medications - Your left atrium (a heart chamber) is larger than 6 cm - You have kidney failure requiring dialysis or liver failure - You are pregnant or plan to become pregnant within 12 months 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

PROCEDURESurgical Ablation

In addition to the concomitant surgery, subjects are required to have amputation or closure (with sutures or ligation) of the left atrial appendage.The Cox Maze IV lesion set is required to be performed.

DEVICECardioblate and Cryoflex hand held devices

The Cardioblate hand held devices consist of the Cardioblate iRF and Cryo surgical ablation devices.


Locations(15)

Stanford Hospitals and Clinic

Palo Alto, California, United States

Adventist Health St. Helena

St. Helena, California, United States

Hartford Healthcare

Hartford, Connecticut, United States

St Vincent Heart Center of Indiana

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Corewell Health

Grand Rapids, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

ProMedica Toledo

Toledo, Ohio, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Intermountain Medical Center

Murray, Utah, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Virginia Mason Heart Institute

Seattle, Washington, United States

Swedish Medical Center

Seattle, Washington, United States

St. Joseph Medical Center

Tacoma, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT03546374


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