Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Persistent Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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AF ablation and AV node ablation

Patients will receive the combined procedure of AF ablation as well as AV node ablation

Group Type EXPERIMENTAL

AF ablation and AV node ablation

Intervention Type PROCEDURE

AF ablation and AV node ablation

AV node ablation

Patient will receive AV node ablation alone

Group Type ACTIVE_COMPARATOR

AV node ablation

Intervention Type PROCEDURE

AV node ablation

Interventions

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AF ablation and AV node ablation

Intervention Type PROCEDURE

AV node ablation

Intervention Type PROCEDURE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No