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
  Purpose

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.


Condition Intervention
Persistent Atrial Fibrillation
Procedure: AF ablation and AV node ablation
Procedure: AV node ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Eastbourne General Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: February 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AF ablation and AV node ablation
Patients will receive the combined procedure of AF ablation as well as AV node ablation
Procedure: AF ablation and AV node ablation
AF ablation and AV node ablation
Active Comparator: AV node ablation
Patient will receive AV node ablation alone
Procedure: AV node ablation
AV node ablation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057485

Contacts
Contact: Steven J Podd, MBBS, MA, MRCP 01323 417400 ext 4132 steven.podd@esht.nhs.uk

Locations
United Kingdom
Eastbourne District General Hospital Recruiting
Eastbourne, East Sussex, United Kingdom, BN21 2UD
Contact: Steven J Podd, MBBS, MA, MRCP    01323 417400 ext 4132    stevenpodd@yahoo.com   
Sponsors and Collaborators
Eastbourne General Hospital
  More Information

No publications provided

Responsible Party: Dr AN Sulke, NHS
ClinicalTrials.gov Identifier: NCT01057485     History of Changes
Other Study ID Numbers: NAFAPAFv1.3
Study First Received: January 26, 2010
Last Updated: May 25, 2010
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Eastbourne General Hospital:
Atrial Fibrillation
Ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014