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Clinical Trials/NCT01057485
NCT01057485
Unknown
Not Applicable

Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation

Eastbourne General Hospital1 site in 1 country50 target enrollmentFebruary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Persistent Atrial Fibrillation
Sponsor
Eastbourne General Hospital
Enrollment
50
Locations
1
Primary Endpoint
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
Last Updated
15 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
January 2012
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Eastbourne General Hospital

Eligibility 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.

Outcomes

Primary Outcomes

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

Study Sites (1)

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