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The purpose of this study is 3 fold:-
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablation Frontiers Ablation | Active Comparator | This group will undergo AF ablation using Ablation Frontiers Technology. |
|
| LASSO ablation | Active Comparator | This group will undergo atrial fibrillation ablation with traditional LASSO technology |
|
| Reveal XT monitoring | Active Comparator | This group will be monitored pre and post ablation using a Reveal XT implantable loop recorder. |
|
| Permanent Pacemaker - dual chamber | Active Comparator | This group will be monitored pre and post ablation with a dual chamber permanent pacemaker |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AF Ablation with Ablation Frontiers Technology | Procedure | AF Ablation with Ablation Frontiers Technology - PVAC, TVAC and MASC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AF Burden | AF Burden post left atrial ablation is defined as the sum of the duration of all atrial tachyarrhythmias expressed as a percentage of the total observation period as assessed by PM Holters. | 12 Months |
| AF Burden | Comparison of AF burden post PVI ablation using a conventional irrigation tip catheter with LASSO guidance (or equivalent) versus Ablation Frontiers Technology using the PVAC, MASC and TVAC catheters via standard trans-septal techniques. | 12 months |
| AF Burden detected | To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the 'gold standard' DDD pacemaker Holter. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Arrhythmia frequency - symptomatic or asymptomatic. | Arrhythmia Frequency is defined as the total number of atrial tachyarrhythmic episodes divided by the observation period, expressed as episodes per day as assessed by PM Holters. | 12 months |
| Time to first episode of AF |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steven J Podd, MBBS, MRCP, BA | Contact | 01323 417400 | 4132 | steven.podd@esht.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Stephen S Furniss, FRCP, MD | East Sussex NHS Trust | Principal Investigator |
| AN Sulke, FRCP, MD | East Sussex NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastbourne District General Hospital | Eastbourne | East Sussex | BN21 2UD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26310300 | Derived | Podd SJ, Sulke AN, Sugihara C, Furniss SS. Phased multipolar radiofrequency pulmonary vein isolation is as effective and safe as conventional irrigated point-to-point ablation. A prospective randomised 1-year implantable cardiac monitoring device follow-up trial. J Interv Card Electrophysiol. 2015 Dec;44(3):257-64. doi: 10.1007/s10840-015-0042-0. Epub 2015 Aug 27. |
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| AF Ablation with LASSO catheter | Procedure | AF Ablation with traditional LASSO catheter |
|
| Reveal XT | Device | Reveal XT implantable loop recorder monitored group |
|
| Permanent Dual Chamber Pacemaker | Device | This group will be monitored with a dual chamber pacemaker with advanced AF monitoring capabilities. |
|
Time to persistent AF is defined as the time from ablation to the first recorded episode of AF |
| 12 months |
| Average AF duration | Average arrhythmia duration is defined as the total duration of atrial arrhythmia divided by the total number of atrial arrhythmia episodes. | 12 months |
| Time to persistent AF. | Time to persistent AF (atrial fibrillation episode lasting for 7 days) | 12 months |
| Average SR duration. | Average sinus rhythm duration is defined as the total duration of sinus rhythm from first atrial arrhythmic episode until last atrial arrhythmic episode divided by the number of atrial arrhythmic episodes minus 1. | 12 months |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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