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The investigators hypothesise that modification of the Atrial Fibrillation (AF) substrate by radiofrequency ablation would improve single procedure success rates for Radio Frequency Ablation (RFA) for Non-paroxysmal AF when compared to that achieved with short-term peri-procedural anti-arrhythmic drug therapy alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary vein isolation | Active Comparator | Patients will undergo pulmonary venous isolation plus pharmacological substrate modification |
|
| Pulmonary vein isolation + Linear Lesions | Experimental | Patients will undergo pulmonary venous isolation plus both pharmacological and interventional substrate modification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary vein isolation (PVI) | Procedure | Using a 4mm irrigated tip radiofrequency ablation catheter a series of lesions >2 mm outside pulmonary vein (PV) ostia will be made to encircle and electrically isolate the pulmonary veins in two ipsilateral pairs (wide area circumferential ablation, WACA). A 20-pole PV mapping catheter will be used to confirm electrical isolation. If the patient is in atrial fibrillation at this stage, sinus rhythm would be restored with electrical cardioversion and PVI would be confirmed in sinus rhythm |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from atrial fibrillation/ atrial tachycardia at 6 months following a single procedure. | Defined as >30 sec of AF/ atrial tachycardia identified on ECG or ambulatory ECG monitoring following a 3 month blanking period. | 12 months |
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Inclusion Criteria:
Ongoing symptoms (European Heart Rhythm Association Class 2 or above) in spite of treatment with rate control medication
Non-paroxysmal atrial fibrillation, as pre-classified as
Persistent AF: AF requiring Electrical/ Chemical cardioversion or that lasting >7 days. These patients may be in AF or in sinus Rhythm at the time of their initial assessment and/ or at the time of their ablation.
Continuous Persistent AF: These patients are persistently in AF with or without antiarrhythmic drug therapy, as confirmed on a 24 hour Holter. They may have undergone previous cardioversion(s).
Sustained Paroxysmal AF with underlying substrate: Patients with Individual AF episode(s) lasting >12 hours but less than 7 days plus one or more of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dhiraj Gupta, MD DM MRCP | Liverpool Heart and Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Heart and Chest Hospital | Liverpool | L14 3PE | United Kingdom | |||
| Royal Brompton and Harefield Hospitals NHS Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25588685 | Derived | Wynn GJ, DAS M, Bonnett LJ, Hall MCS, Snowdon RL, Waktare JEP, Modi S, Todd DM, Gupta D. A novel marker to predict early recurrence after atrial fibrillation ablation: the ablation effectiveness quotient. J Cardiovasc Electrophysiol. 2015 Apr;26(4):397-403. doi: 10.1111/jce.12618. Epub 2015 Feb 25. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 14, 2017 | |
| Reset | Apr 24, 2017 |
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|
| Pulmonary vein isolation + linear lesions | Procedure | Using a 4mm irrigated tip radiofrequency ablation catheter a series of lesions >2 mm outside PV ostia will be made to encircle and electrically isolate the pulmonary veins in two ipsilateral pairs (wide area circumferential ablation, WACA)34. A 20-pole PV mapping catheter will be used to confirm electrical isolation. Once PVI has been achieved, patients will go onto to receive additional linear ablation lesions. These will include a left atrial roof line, mitral isthmus line, (including ablation inside the coronary sinus if necessary), and ablation on the cavotricuspid isthmus. If the patient is in atrial fibrillation at this stage, the acute end-point would be signal obliteration at the ablated area. Once sinus rhythm is restored with electrical cardioversion, PVI would be confirmed in sinus rhythm and conduction block across the LA roof line, Mitral line and CTI will then be verified with appropriate pacing manoeuvres. |
|
| Pharmacological Substrate modification | Drug | at least 6 weeks therapy with oral amiodarone prior to the ablation procedure and 6 weeks post. |
|
| London |
| United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 14, 2017 | Apr 24, 2017 |
| 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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