Tailored Treatment of Permanent Atrial Fibrillation (TTOP-AF)

Medtronic

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Procedure: Medtronic Cardiac Ablation System; Drug: Class I or III Antiarrhythmic Medications

Study type: Interventional

Funder types: Industry

Identifiers

NCT00514735

AFI-30

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

210 participants in 2 patient groups

1

Experimental group

Description:

Ablation Management

Treatment:

Procedure: Medtronic Cardiac Ablation System

2

Active Comparator group

Description:

Medical Management

Treatment:

Drug: Class I or III Antiarrhythmic Medications