Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation (NAFAPAF)

Eastbourne General Hospital

Status: Unknown

Conditions: Persistent Atrial Fibrillation

Treatments: Procedure: AV node ablation; Procedure: AF ablation and AV node ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT01057485

NAFAPAFv1.3

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

AF ablation and AV node ablation

Experimental group

Description:

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

Treatment:

Procedure: AF ablation and AV node ablation

AV node ablation

Active Comparator group

Description:

Patient will receive AV node ablation alone

Treatment:

Procedure: AV node ablation