Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation

Persistent Atrial Fibrillation Clinical Trial

— NAFAPAF  

Official title:

Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01057485
• Other study ID #: NAFAPAFv1.3
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2010
• Last updated: May 25, 2010
• Start date: February 2010
• Est. completion date: January 2012

Study information

• Verified date: January 2010
• Source: Eastbourne General Hospital
• Contact: Steven J Podd, MBBS, MA, MRCP
• Phone: 01323 417400
• Email: steven.podd[@]esht.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Eastbourne District General Hospital	Eastbourne	East Sussex

Sponsors (1)

Lead Sponsor	Collaborator
Eastbourne General Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes