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Clinical Trials/NCT02528604
NCT02528604
Completed
Phase 4

Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation in Over 65s - The CAPAPAF-65 Study

Eastbourne General Hospital2 sites in 1 country75 target enrollmentStarted: July 2016Last updated:

Overview

Phase
Phase 4
Status
Completed
Sponsor
Eastbourne General Hospital
Enrollment
75
Locations
2
Primary Endpoint
AF recurrence

Overview

Brief Summary

Comparison of (i) catheter ablation, (ii) electrical cardioversion and (iii) pacemaker implantation with AV node ablation for patients over 65 years of age with persistent Atrial Fibrillation.

Detailed Description

the National Institute for Health and Care Excellence (NICE) suggest the following treatments options can be considered for patients with recurrent persistent atrial fibrillation:

  1. Direct current cardioversion (DCCV) with concomitant anti-arrhythmic treatment.
  2. Permanent pacemaker implantation (PPM) and atrio-ventricular (AV) node ablation.
  3. Left atrial catheter ablation.

These treatment options have not been directly compared and each has their own advantages and disadvantages.

  1. DC cardioversion is highly successful at restoring sinus rhythm and is a relatively cheap intervention. There is however a high recurrence rate of AF and cardioversion may need to be repeated multiple times.
  2. Permanent pacemaker implantation and AV node ablation, 'ablate and pace' therapy provides rapid relief of symptoms and improved quality of life. Patients remain in atrial fibrillation but have a regular heart rhythm and controlled rate and avoid potential side-effects of medications. Following AV node ablation patients are dependent on the pacemaker and as such this treatment option is usually reserved for those over 65 years or age. Costs are modest and both the pacemaker insertion and AV node ablation procedures take less than 1 hour to perform.
  3. Catheter ablation for atrial fibrillation aims to restore and sustain sinus rhythm. Procedural success rates are 50-60% after a single procedure and 80-85% after repeat procedures and it can take several months for all procedures in an ablation strategy to be performed. Procedural costs are high due to the equipment used and time taken for each ablation, usually 1.5-4 hours.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with symptomatic persistent atrial fibrillation of less than 1-year duration.
  • Patients must be over 65 years old.
  • Patients give informed consent prior to participating in this study.

Exclusion Criteria

  • Paroxysmal atrial fibrillation.
  • Long-standing persistent or permanent atrial fibrillation.
  • Previous pacemaker implantation.
  • Previous atrial ablation.
  • Patient is unable to take warfarin or other oral anti-coagulant medication.
  • Patient is suffering with unstable angina in last one week.
  • Patient has had a myocardial infarction within last two months.
  • Patient is expecting or has had major cardiac surgery within last two months.
  • Patient is participating in a conflicting study.
  • Patient is unable to perform exercise testing.

Outcomes

Primary Outcomes

AF recurrence

Time Frame: 12 months

Time to recurrence of persistent AF

Secondary Outcomes

  • Sleep apnoea(6 months)
  • Exercise performance(12 months)
  • Patient experience of procedure(Baseline)
  • AF recurrence >2minutes(12 months)
  • Symptoms / QOL(12 months)
  • AF burden(12 months)
  • Total costs of the treatment options(12 months)

Investigators

Sponsor
Eastbourne General Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rick Veasey

Consultant Cardiologist

Eastbourne General Hospital

Study Sites (2)

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