Electrical Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation (CAPAPAF-65)

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

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.

Study Overview

• Status: Completed
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Procedure: Catheter ablation; Device: Implantable loop recorder; Procedure: Pacemaker and AV node ablation; Procedure: DC Cardioversion

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • East Sussex
    • Eastbourne, East Sussex, United Kingdom, BN21 2UD
      • Eastbourne District General Hospital
    • St Leonards-on-Sea, East Sussex, United Kingdom, TN37 7RD
      • Conquest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Catheter Ablation; Left atrial catheter ablation for persistent atrial fibrillation and implantable loop recorder.	Procedure: Catheter ablation; Left atrial ablation of persistent atrial fibrillation and implantable loop recorder insertion.; Device: Implantable loop recorder
Active Comparator: Pacemaker and AV node ablation; Participants will have a permanent pacemaker implant followed by AV node ablation	Procedure: Pacemaker and AV node ablation; Permanent pacemaker implant followed by AV node ablation
Active Comparator: DC cardioversion; Participants will have electrical cardioversion with concomitant anti-arrhythmic therapy and implantable loop recorder.	Device: Implantable loop recorder; Procedure: DC Cardioversion; Electrical cardioversion for Persistent Atrial Fibrillation and implantable loop recorder insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AF recurrence	Time to recurrence of persistent AF	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient experience of procedure	Patient experience of each procedure will be assessed by validated questionnaires	Baseline
Total costs of the treatment options		12 months
AF recurrence >2minutes	Time to recurrence of AF episode > 2 minutes	12 months
Symptoms / QOL	To assess differences in symptoms and QOL	12 months
Exercise performance	To measure the three treatment effects on VO2 max over time by means of cardiopulmonary exercise testing.	12 months
AF burden	To measure the three treatment effects on AF burden	12 months
Sleep apnoea	To assess the impact of the three treatment options on sleep apnoea scores	6 months

Collaborators and Investigators

• Sponsor: Eastbourne General Hospital
• Investigators: Principal Investigator: Rick A Veasey, MRCP, MD, Consultant Cardiologist

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: August 18, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Actual): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 26, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Catheter Ablation; Permanent pacemaker; AV node ablation; Electrical Cardioversion; Implantable loop recorder
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CAPAPAF-65 V2.0