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

NCT ID: NCT02528604

Last Updated: 2018-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-09-30

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.

Conditions

Persistent Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Catheter Ablation

Left atrial catheter ablation for persistent atrial fibrillation and implantable loop recorder.

Group Type: ACTIVE_COMPARATOR

Catheter ablation

Intervention Type: PROCEDURE

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

Implantable loop recorder

Intervention Type: DEVICE

Pacemaker and AV node ablation

Participants will have a permanent pacemaker implant followed by AV node ablation

Group Type: ACTIVE_COMPARATOR

Pacemaker and AV node ablation

Intervention Type: PROCEDURE

Permanent pacemaker implant followed by AV node ablation

DC cardioversion

Participants will have electrical cardioversion with concomitant anti-arrhythmic therapy and implantable loop recorder.

Group Type: ACTIVE_COMPARATOR

DC Cardioversion

Intervention Type: PROCEDURE

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

Implantable loop recorder

Intervention Type: DEVICE

Interventions

Catheter ablation

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

Intervention Type: PROCEDURE

Pacemaker and AV node ablation

Permanent pacemaker implant followed by AV node ablation

Intervention Type: PROCEDURE

DC Cardioversion

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

Intervention Type: PROCEDURE

Implantable loop recorder

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastbourne General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rick Veasey

Consultant Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rick A Veasey, MRCP, MD

Role: PRINCIPAL_INVESTIGATOR

Consultant Cardiologist

Locations

Eastbourne District General Hospital

Eastbourne, East Sussex, United Kingdom

Conquest Hospital

Saint Leonards-on-Sea, East Sussex, United Kingdom

Countries

United Kingdom

Other Identifiers

CAPAPAF-65 V2.0

Identifier Type: -

Identifier Source: org_study_id