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Completed

NCT Number: NCT02528604

Electrical Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Eastbourne District General Hospital, Eastbourne, East Sussex, United Kingdom

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About this study

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

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

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

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Patient is mentally incapacitated and cannot consent or comply with follow-up.
  • Patient has New York Heart Association (NYHA) class III/IV heart failure.
  • Patient has left ventricular ejection fraction (LVEF) less than 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).

Treatment and study plan

Catheter ablation

Procedure

Left atrial ablation of persistent atrial fibrillation and implantable loop recorder insertion.

Pacemaker and AV node ablation

Procedure

Permanent pacemaker implant followed by AV node ablation

DC Cardioversion

Procedure

Electrical cardioversion for Persistent Atrial Fibrillation and implantable loop recorder insertion.

Implantable Loop Recorder

Device

Primary outcomes

  1. AF recurrence

    Time frame: 12 months

    Time to recurrence of persistent AF

Secondary outcomes

  1. Patient experience of procedure

    Time frame: Baseline

    Patient experience of each procedure will be assessed by validated questionnaires

  2. Total costs of the treatment options

    Time frame: 12 months

  3. AF recurrence >2minutes

    Time frame: 12 months

    Time to recurrence of AF episode > 2 minutes

  4. Symptoms / QOL

    Time frame: 12 months

    To assess differences in symptoms and QOL

  5. Exercise performance

    Time frame: 12 months

    To measure the three treatment effects on VO2 max over time by means of cardiopulmonary exercise testing.

  6. AF burden

    Time frame: 12 months

    To measure the three treatment effects on AF burden

  7. Sleep apnoea

    Time frame: 6 months

    To assess the impact of the three treatment options on sleep apnoea scores

Sponsors and collaborators

Lead sponsor

Eastbourne General Hospital

Other

Registry information

Official study title

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

Acronym: CAPAPAF-65

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 19, 2015
Registry last updated
Sep 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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