Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation

Not Applicable

• Conditions: Persistent Atrial Fibrillation
• Interventions: Procedure: AF ablation and AV node ablation; Procedure: AV node ablation

• Registration Number: NCT01057485
• Lead Sponsor: Eastbourne General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-01
• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-01-26
• Study First Posted: 2010-01-27
• Study Start: 2010-02
• Last Update Submitted: 2010-05-25
• Last Update Posted: 2010-05-26
• Primary Completion: 2011-01
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AF ablation and AV node ablation	AF ablation and AV node ablation	Patients will receive the combined procedure of AF ablation as well as AV node ablation
AV node ablation	AV node ablation	Patient will receive AV node ablation alone

Primary Outcome Measures

Name	Time	Method
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	1 year

Trial Locations

Locations (1)

Eastbourne District General Hospital; 🇬🇧 Eastbourne, East Sussex, United Kingdom