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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.
the National Institute for Health and Care Excellence (NICE) suggest the following treatments options can be considered for patients with recurrent persistent atrial fibrillation:
These treatment options have not been directly compared and each has their own advantages and disadvantages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter Ablation | Active Comparator | Left atrial catheter ablation for persistent atrial fibrillation and implantable loop recorder. |
|
| Pacemaker and AV node ablation | Active Comparator | Participants will have a permanent pacemaker implant followed by AV node ablation |
|
| DC cardioversion | Active Comparator | Participants will have electrical cardioversion with concomitant anti-arrhythmic therapy and implantable loop recorder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter ablation | Procedure | Left atrial ablation of persistent atrial fibrillation and implantable loop recorder insertion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AF recurrence | Time to recurrence of persistent AF | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient experience of procedure | Patient experience of each procedure will be assessed by validated questionnaires | Baseline |
| Total costs of the treatment options | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rick A Veasey, MRCP, MD | Consultant Cardiologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastbourne District General Hospital | Eastbourne | East Sussex | BN21 2UD | United Kingdom | ||
| Conquest Hospital |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| Pacemaker and AV node ablation | Procedure | Permanent pacemaker implant followed by AV node ablation |
|
| DC Cardioversion | Procedure | Electrical cardioversion for Persistent Atrial Fibrillation and implantable loop recorder insertion. |
|
| Implantable loop recorder | Device |
|
| AF recurrence >2minutes | Time to recurrence of AF episode > 2 minutes | 12 months |
| Symptoms / QOL | To assess differences in symptoms and QOL | 12 months |
| Exercise performance | To measure the three treatment effects on VO2 max over time by means of cardiopulmonary exercise testing. | 12 months |
| AF burden | To measure the three treatment effects on AF burden | 12 months |
| Sleep apnoea | To assess the impact of the three treatment options on sleep apnoea scores | 6 months |
| Saint Leonards-on-Sea |
| East Sussex |
| TN37 7RD |
| United Kingdom |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |