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

Primary Purpose

Persistent Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Catheter ablation
Pacemaker and AV node ablation
DC Cardioversion
Implantable loop recorder
Sponsored by
Eastbourne General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Catheter Ablation, Permanent pacemaker, AV node ablation, Electrical Cardioversion, Implantable loop recorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Eastbourne District General Hospital
  • Conquest Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Catheter Ablation

Pacemaker and AV node ablation

DC cardioversion

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

AF recurrence
Time to recurrence of persistent AF

Secondary Outcome Measures

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

Full Information

First Posted
August 18, 2015
Last Updated
September 26, 2018
Sponsor
Eastbourne General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02528604
Brief Title
Electrical Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation
Acronym
CAPAPAF-65
Official Title
Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation in Over 65s - The CAPAPAF-65 Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastbourne General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Direct current cardioversion (DCCV) with concomitant anti-arrhythmic treatment. Permanent pacemaker implantation (PPM) and atrio-ventricular (AV) node ablation. Left atrial catheter ablation. These treatment options have not been directly compared and each has their own advantages and disadvantages. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
Catheter Ablation, Permanent pacemaker, AV node ablation, Electrical Cardioversion, Implantable loop recorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Catheter Ablation
Arm Type
Active Comparator
Arm Description
Left atrial catheter ablation for persistent atrial fibrillation and implantable loop recorder.
Arm Title
Pacemaker and AV node ablation
Arm Type
Active Comparator
Arm Description
Participants will have a permanent pacemaker implant followed by AV node ablation
Arm Title
DC cardioversion
Arm Type
Active Comparator
Arm Description
Participants will have electrical cardioversion with concomitant anti-arrhythmic therapy and implantable loop recorder.
Intervention Type
Procedure
Intervention Name(s)
Catheter ablation
Intervention Description
Left atrial ablation of persistent atrial fibrillation and implantable loop recorder insertion.
Intervention Type
Procedure
Intervention Name(s)
Pacemaker and AV node ablation
Intervention Description
Permanent pacemaker implant followed by AV node ablation
Intervention Type
Procedure
Intervention Name(s)
DC Cardioversion
Intervention Description
Electrical cardioversion for Persistent Atrial Fibrillation and implantable loop recorder insertion.
Intervention Type
Device
Intervention Name(s)
Implantable loop recorder
Primary Outcome Measure Information:
Title
AF recurrence
Description
Time to recurrence of persistent AF
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Patient experience of procedure
Description
Patient experience of each procedure will be assessed by validated questionnaires
Time Frame
Baseline
Title
Total costs of the treatment options
Time Frame
12 months
Title
AF recurrence >2minutes
Description
Time to recurrence of AF episode > 2 minutes
Time Frame
12 months
Title
Symptoms / QOL
Description
To assess differences in symptoms and QOL
Time Frame
12 months
Title
Exercise performance
Description
To measure the three treatment effects on VO2 max over time by means of cardiopulmonary exercise testing.
Time Frame
12 months
Title
AF burden
Description
To measure the three treatment effects on AF burden
Time Frame
12 months
Title
Sleep apnoea
Description
To assess the impact of the three treatment options on sleep apnoea scores
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rick A Veasey, MRCP, MD
Organizational Affiliation
Consultant Cardiologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastbourne District General Hospital
City
Eastbourne
State/Province
East Sussex
ZIP/Postal Code
BN21 2UD
Country
United Kingdom
Facility Name
Conquest Hospital
City
St Leonards-on-Sea
State/Province
East Sussex
ZIP/Postal Code
TN37 7RD
Country
United Kingdom

12. IPD Sharing Statement

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

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