Clinical trial NCT02528604: Electrical Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation
Official title: Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation in Over 65s - The CAPAPAF-65 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Persistent Atrial Fibrillation
Keywords: Catheter Ablation
Permanent pacemaker
AV node ablation
Electrical Cardioversion
Implantable loop recorder
Lead sponsor: Eastbourne General Hospital
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: AF recurrence
timeFrame: 12 months
Secondary outcomes:
measure: Patient experience of procedure
timeFrame: Baseline
measure: Total costs of the treatment options
timeFrame: 12 months
measure: AF recurrence >2minutes
timeFrame: 12 months
measure: Symptoms / QOL
timeFrame: 12 months
measure: Exercise performance
timeFrame: 12 months
measure: AF burden
timeFrame: 12 months
measure: Sleep apnoea
timeFrame: 6 months
Other outcomes:
Locations:
city: Eastbourne
country: United Kingdom
facility: Eastbourne District General Hospital
state: East Sussex
city: St Leonards-on-Sea
country: United Kingdom
facility: Conquest Hospital
state: East Sussex
Study officials:
affiliation: Consultant Cardiologist
name: Rick A Veasey, MRCP, MD
role: PRINCIPAL_INVESTIGATOR
References: