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Decision to discontinue in light of new evidence demonstrating that the intervention in question is not effective.
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| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
| Royal Brompton & Harefield NHS Foundation Trust | OTHER |
| St George's University Hospitals NHS Foundation Trust | OTHER |
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RABLAP-AF will compare pulmonary vein isolation (PVI) in combination with posterior wall isolation (PWI) for patients with persistent atrial fibrillation (AF).
Ablation for AF has a high success rate for patients with paroxysmal AF, but success rates for persistent AF remain significantly lower. These patients frequently have more advanced disease in their left atrium than those with paroxysmal AF.
A common practice is to perform left atrial PWI in addition to PVI in order to reduce AF recurrence. This approach has conflicting evidence behind it and a large scale clinical trial in those with advanced disease is required. The investigators hope to fill this gap with RABLAP-AF.
The investigators will randomise patients with advanced atrial disease 1:1 to PVI+PWI or PVI alone. All patients will receive implantable loop recorders two months prior to the ablation procedure in order to accurately assess the effect of PWI and compare arrhythmia burden before and after ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - PVI + PWI | Active Comparator | These patients will receive pulmonary vein isolation and posterior wall isolation. |
|
| Group 2 - PVI only | Other | These patients will receive pulmonary vein isolation only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracardiac Catheter Ablation | Procedure | Both arms will receive intracardiac catheter ablation procedures as described. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first day with ATA burden of 12 hours or greater | Time to day with atrial tachyarrhythmia burden lasting 12 hours or greater, following a 3 month blanking period post-ablation | From 3 months post ablation to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first day with ATA burden of 24 hours | Time to first day with atrial tachyarrhythmia burden of 24 hours, following a 3 month blanking period post-ablation | From 3 months post ablation to 12 months |
| Time to first day with ATA burden of 60 minutes or greater |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome: Number of patients with procedural complications (<2 months post procedure) | Number of patients suffering a procedure-related complication within 2 months of an invasive procedure as defined in the study protocol | Within 2 months of protocol-required invasive procedures |
| Safety Outcome: Number of patients undergoing planned and unplanned cardiovascular-related hospitalisations |
Inclusion criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Dhiraj Gupta, MD | Liverpool Heart & Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Heart & Chest Hospital | Liverpool | L14 3PE | United Kingdom |
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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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| University Hospital Plymouth NHS Trust |
| OTHER |
| South Tees Hospitals NHS Foundation Trust | OTHER |
| Manchester University NHS Foundation Trust | OTHER_GOV |
| Guy's and St Thomas' NHS Foundation Trust | OTHER |
| Papworth Hospital NHS Foundation Trust | OTHER_GOV |
| Portsmouth Hospitals NHS Trust | OTHER_GOV |
| University Hospitals Dorset NHS Foundation Trust | OTHER_GOV |
| University Hospital Birmingham NHS Foundation Trust | OTHER |
| Onze Lieve Vrouw Hospital | OTHER |
| AZ Sint-Jan AV | OTHER |
| University of Liverpool | OTHER |
A randomised controlled trial with two arms: 1) Pulmonary vein isolation + posterior wall isolation; 2) Pulmonary vein isolation alone
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Patients and operators will be aware of the treatment arm. Researchers interpreting and assessing outcome data will be blinded to treatment received.
Time to first day with atrial tachyarrhythmia burden of 60 minutes or greater, following a 3 month blanking period post-ablation |
| From 3 months post ablation to 12 months |
| Number of patients with >= 75% reduction in cumulative burden of AF between pre-ablation and months 3-12 | AF burden (assessed by loop recorder) will be analysed in the 2 months pre-ablation and compared with the 9 months post-blanking period. This outcome will assess the number of patients who achieve greater than or equal to 75% reduction. | 12 months |
| Reduction in burden of AF between pre-ablation and months 3-12 | AF burden (assessed by loop recorder) will be analysed in the 2 months pre-ablation and compared with the 9 months post-blanking period. This outcome will assess the average % reduction in AF burden between these time periods. | 12 months |
| Difference in AFEQT questionnaire between baseline and month 12 | Differences in quality of life indicators as measured by the "AF Effect on QualiTy of life survey" (AFEQT) between baseline and 12 month follow-up | 12 months |
| Difference in EQ5D questionnaire between baseline and month 12 | Differences in quality of life indicators as measured by the "EuroQol 5 Dimension survey" (EQ5D) questionnaire between baseline and 12 month follow-up | 12 months |
| Difference in VAS between baseline and month 12 | Differences in quality of life indicators as measured by "Visual Analogue Scale" (VAS) between baseline and 12 month follow-up | 12 months |
| Use of antiarrhythmic drugs from month 3 onwards | Number of patients requiring antiarrhythmic drugs following the 3 month blanking period. | From 3 months post ablation to 12 months |
| Use of direct current cardioversion or repeat ablation | Number of patients requiring cardioversion or repeat ablation | From 3 months post ablation to 12 months |
Number of patients who are hospitalised (planned or unplanned) for cardiovascular reasons |
| 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |