Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation

Overview

The purpose of the study is to assess combining AF ablation, with AV node ablation and pacemaker implantation for patients suffering with 'irregular heartbeats' or atrial fibrillation. The study will last 13 months.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: January 2011

Interventions

  • Procedure: AF ablation and AV node ablation
    • AF ablation and AV node ablation
  • Procedure: AV node ablation
    • AV node ablation

Arms, Groups and Cohorts

  • Experimental: AF ablation and AV node ablation
    • Patients will receive the combined procedure of AF ablation as well as AV node ablation
  • Active Comparator: AV node ablation
    • Patient will receive AV node ablation alone

Clinical Trial Outcome Measures

Primary Measures

  • To measure the two treatment effects on VO2 max over time by means of cardiopulmonary exercise testing.To measure the two treatment effects on 6-minute hall walk distance.Echocardiographic parameters
    • Time Frame: 1 year

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with symptomatic drug refractory atrial fibrillation. – Patients who have had pacemaker implantation and AV node ablation with ongoing symptoms. – Patients will already be refractory to at least 2 rate or rhythm control drugs. – Patients must be over 18 years old. – Patients give informed consent form prior to participating in this study. Exclusion Criteria:

  • Patient is suffering with unstable angina in last 1 week. – Patient has had a myocardial infarction within last 2 months. – Patient is expecting or has had major cardiac surgery within last 2 months. – Patient is participating in a conflicting study. – Patient is unable to perform exercise testing. – Patient is mentally incapacitated and cannot consent or comply with follow-up. – Patient has NYHA class III/ IV heart failure. – Patient has LVEF <35% not secondary to tachycardia. – Pregnancy. – Patient suffers with other cardiac rhythm disorders. – Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eastbourne General Hospital
  • Provider of Information About this Clinical Study
    • Dr AN Sulke, NHS
  • Overall Contact(s)
    • Steven J Podd, MBBS, MA, MRCP, 01323 417400, steven.podd@esht.nhs.uk

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