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| Name | Class |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
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This trial aims to develop evidence based curative treatment with optimal net benefit for patients with Brugada syndrome.
This trial aims to develop evidence based curative treatment with optimal net benefit for patients with Brugada syndrome. Since a recent non-randomized pilot study and scarce case reports documented potential clinical benefit of epicardial ablation of fragmented electrograms in the region of the right ventricular outflow tract, patients in this trial will be randomized to continued implanted cardioverter defibrillator therapy (control arm) or ablation of areas of fragmented electrograms in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy (intervention arm). A projected 92 patients in each group will be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | No Intervention | Control arm - continued implanted cardioverter defibrillator therapy | |
| Intervention Arm | Active Comparator | ablation of areas of fragmented signal in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy |
|
| Single Cross Over Arm | Other | these patients were initially assigned to the control arm of the study. When these patients met the primary outcome of the study it is allowed for these patients to be included in the intervention arm and/or to start quinidine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter Ablation | Procedure | catheter ablation of fragmented signal in the right ventricular outflow tract |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom of Ventricular Fibrillation/Tachycardia Recurrences | Survival from ventricular fibrillation of shocked ventricular arrhythmias causing ICD discharge | 3 year followup |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom without drug | Freedom of shocked ventricular arrhythmias without the use of anti-arrhythmic drugs during 3 years of follow-up | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Koonlawee Nademanee, MD | Pacific Rim Electrophysiology Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center, University of Amsterdam | Amsterdam | Netherlands | ||||
| Bhumipol Adulyadej Hospital, Royal Thai Air Force |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26516000 | Background | Nademanee K, Raju H, de Noronha SV, Papadakis M, Robinson L, Rothery S, Makita N, Kowase S, Boonmee N, Vitayakritsirikul V, Ratanarapee S, Sharma S, van der Wal AC, Christiansen M, Tan HL, Wilde AA, Nogami A, Sheppard MN, Veerakul G, Behr ER. Fibrosis, Connexin-43, and Conduction Abnormalities in the Brugada Syndrome. J Am Coll Cardiol. 2015 Nov 3;66(18):1976-1986. doi: 10.1016/j.jacc.2015.08.862. | |
| 21403098 |
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Medical journals, abstract submissions and results database
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| ID | Term |
|---|---|
| D053840 | Brugada Syndrome |
| D003643 | Death |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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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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| Bangkok |
| Thailand |
| Chulalongkorn University | Bangkok | Thailand |
| Pacific Rim Electrophysiology Research Institute Data Coordinating Center | Bangkok | Thailand |
| Ramathibodi Hospital | Bangkok | Thailand |
| Chiang Mai University | Chiang Mai | Thailand |
| Background |
| Nademanee K, Veerakul G, Chandanamattha P, Chaothawee L, Ariyachaipanich A, Jirasirirojanakorn K, Likittanasombat K, Bhuripanyo K, Ngarmukos T. Prevention of ventricular fibrillation episodes in Brugada syndrome by catheter ablation over the anterior right ventricular outflow tract epicardium. Circulation. 2011 Mar 29;123(12):1270-9. doi: 10.1161/CIRCULATIONAHA.110.972612. Epub 2011 Mar 14. |
| 26480928 | Background | Ten Sande JN, Coronel R, Conrath CE, Driessen AH, de Groot JR, Tan HL, Nademanee K, Wilde AA, de Bakker JM, van Dessel PF. ST-Segment Elevation and Fractionated Electrograms in Brugada Syndrome Patients Arise From the Same Structurally Abnormal Subepicardial RVOT Area but Have a Different Mechanism. Circ Arrhythm Electrophysiol. 2015 Dec;8(6):1382-92. doi: 10.1161/CIRCEP.115.003366. Epub 2015 Oct 19. |
| 26671932 | Background | Wilde AA, Nademanee K. Epicardial Substrate Ablation in Brugada Syndrome: Time for a Randomized Trial! Circ Arrhythm Electrophysiol. 2015 Dec;8(6):1306-8. doi: 10.1161/CIRCEP.115.003500. No abstract available. |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |