Tailored Treatment of Permanent Atrial Fibrillation

Completed · Phase 3

Conditions studied: Atrial Fibrillation

In brief

The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac Ablation System compared to medical therapy in the persistent and long-standing persistent atrial fibrillation population.

Key facts

Study ID

NCT00514735

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

210

Starts

2007-05-01

Expected to finish

2010-11-01

Last updated by the study team

2018-10-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of symptomatic, continuous atrial fibrillation defined as: Continuous atrial fibrillation lasting greater than 1 year but less than 4 years or nonself-terminating atrial fibrillation, lasting greater than 7 days but no more than 1 year, with at least one failed direct current cardioversion. A failed cardioversion was defined as an unsuccessful cardioversion or one in which normal sinus rhythm was established but not maintained beyond 7 days.
• Atrial fibrillation symptoms included the following: palpitations, fatigue,exertional dyspnea, exercise intolerance
• Age between 18 and 70 years
• Failure of at least one Class I or III rhythm control drug
• Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.

You may not qualify if…

• Structural heart disease of clinical significance including:
• Previous cardiac surgery (excluding coronary artery bypass graft and mitral valve repair)
• Symptoms of congestive heart failure including, but not limited to, New York Heart Association (NYHA) Class III or IV congestive heart failure and/or documented ejection fraction <40% measured by acceptable cardiac testing
• Left atrial diameter >55 mm
• Moderate to severe mitral or aortic valvular heart disease
• Stable/unstable angina or ongoing myocardial ischemia
• Myocardial infarction (MI) within 3 months of enrollment
• Congenital heart disease (not including atrial septal defect or patent foramen ovale without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
• Prior atrial septal defect of patent foramen ovale closure with a device using a percutaneous approach
• Hypertrophic cardiomyopathy (left ventricular septal wall thickness >1.5 cm)
• Pulmonary hypertension (mean or systolic pulmonary artery pressure >50 mm Hg on Doppler echo)
• Any prior ablation for atrial fibrillation
• Enrollment in any other ongoing arrhythmia study
• Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study
• Active infection or sepsis
• Any history of cerebral vascular disease including stroke or transient ischemic attacks
• Pregnancy or lactation
• Left atrial thrombus at the time of ablation
• Untreatable allergy to contrast media
• Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
• History of blood clotting (bleeding or thrombotic) abnormalities
• Known sensitivities to heparin or warfarin
• Severe chronic obstructive pulmonary disease (defined as forced expiratory volume 1 (FEV1) <1)
• Severe co-morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate

Where it is running

• Arizona Arrhythmia Research Center — Scottsdale, Arizona, United States
• UCLA Cardiac Arrhythmia Center — Los Angeles, California, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Emory Crawford Long Hospital — Atlanta, Georgia, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Krannert Institute of Cardiology — Indianapolis, Indiana, United States
• Genesis Medical Center — Davenport, Iowa, United States
• Iowa Heart Center — Des Moines, Iowa, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Washington Adventist Hospital — Takoma Park, Maryland, United States
• Massachusetts General Hospital Cardiac Arrhythmia — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Spectrum Health Research Department — Grand Rapids, Michigan, United States
• University of Rochester — Rochester, New York, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• The Ohio State University — Columbus, Ohio, United States
• Consultants in Cardiovascular Diseases — Erie, Pennsylvania, United States
• Austin Heart — Austin, Texas, United States
• Texas Heart Institute at St. Luke's Episcopal — Houston, Texas, United States
• Sentara Cardiovascular Research Institute — Norfolk, Virginia, United States
• St. Antonius Ziekenhuis — Nieuwegein, Netherlands

Full record on ClinicalTrials.gov

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