Tailored Treatment of Permanent Atrial Fibrillation

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medtronic Atrial Fibrillation Solutions; Medtronic Cardiac Rhythm and Heart Failure
• Treatments: Anti-Arrhythmia Agents

Criteria

INCLUSION CRITERIA:

• 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.

EXCLUSION CRITERIA:

• 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