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

Persistent Atrial Fibrillation Clinical Trial

— CAPAPAF-65  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528604
• Other study ID #: CAPAPAF-65 V2.0
• Status: Completed
• Phase: Phase 4
• Start date: July 2016
• Est. completion date: September 2018

Study information

• Verified date: September 2018
• Source: Eastbourne General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Procedure:
• Catheter ablation
Left atrial ablation of persistent atrial fibrillation and implantable loop recorder insertion.
• Pacemaker and AV node ablation
Permanent pacemaker implant followed by AV node ablation
• DC Cardioversion
Electrical cardioversion for Persistent Atrial Fibrillation and implantable loop recorder insertion.

Device:
• Implantable loop recorder

Locations

Country	Name	City	State
United Kingdom	Eastbourne District General Hospital	Eastbourne	East Sussex
United Kingdom	Conquest Hospital	St Leonards-on-Sea	East Sussex

Sponsors (1)

Lead Sponsor	Collaborator
Eastbourne General Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

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