Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-02 @ 10:54 AM
Study NCT ID:
NCT02528604
Status:
COMPLETED
Last Update Posted:
2018-09-27
First Post:
2015-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrical Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation
Sponsor:
Eastbourne General Hospital
Organization:
Study Overview
Official Title:
Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation in Over 65s - The CAPAPAF-65 Study
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPAPAF-65
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: