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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Eastbourne General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eastbourne General Hospital
ClinicalTrials.gov Identifier:
NCT01057485
First received: January 26, 2010
Last updated: May 25, 2010
Last verified: January 2010

January 26, 2010
May 25, 2010
February 2010
January 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01057485 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation
Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Persistent Atrial Fibrillation
  • Procedure: AF ablation and AV node ablation
    AF ablation and AV node ablation
  • Procedure: AV node ablation
    AV node ablation
  • Experimental: AF ablation and AV node ablation
    Patients will receive the combined procedure of AF ablation as well as AV node ablation
    Intervention: Procedure: AF ablation and AV node ablation
  • Active Comparator: AV node ablation
    Patient will receive AV node ablation alone
    Intervention: Procedure: AV node ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
January 2012
January 2011   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact: Steven J Podd, MBBS, MA, MRCP 01323 417400 ext 4132 steven.podd@esht.nhs.uk
United Kingdom
 
NCT01057485
NAFAPAFv1.3
No
Dr AN Sulke, NHS
Eastbourne General Hospital
Not Provided
Not Provided
Eastbourne General Hospital
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP