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The study was stopped due to futility
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The BERLIN VT study is designed to evaluate the impact of prophylactic ventricular tachycardia (VT) ablation on all-cause mortality and unplanned hospital admission for congestive heart failure or symptomatic ventricular tachycardia/ventricular fibrillation (VF) when compared to VT ablation after the third appropriate implantable cardioverter-defibrillator (ICD) shock.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 (TG1) | Experimental | Prophylactic VT ablation prior to ICD implantation |
|
| Treatment Group 2 (TG2) | Other | ICD implantation and best medical care until the third appropriate ICD shock occurs and catheter ablation thereafter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VT ablation | Procedure | Catheter ablation of ventricular tachycardia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first event comprising all-cause mortality, unplanned hospital admission for congestive heart failure and unplanned hospital admission for symptomatic ventricular tachycardia (VT)/ ventricular fibrillation (VF) | From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first sustained ventricular tachycardia (VT)/ ventricular fibrillation (VF) | From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months.. | |
| Time to first appropriate implantable cardioverter-defibrillator (ICD) therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karl-Heinz Kuck, Prof. | Asklepios Klinik St. Georg, Hamburg (Germany) | Principal Investigator |
| Stephan Willems, Prof. | Universitäres Herzzentrum, Hamburg (Germany) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Köln | Cologne | 50937 | Germany | |||
| Asklepios Klinik St. Georg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31072848 | Background | Tilz RR, Kuck KH, Kaab S, Wegscheider K, Thiem A, Wenzel B, Willems S, Steven D. Rationale and design of BERLIN VT study: a multicenter randomised trial comparing preventive versus deferred ablation of ventricular tachycardia. BMJ Open. 2019 May 9;9(5):e022910. doi: 10.1136/bmjopen-2018-022910. | |
| 32000514 | Derived |
| Label | URL |
|---|---|
| Design Paper | View source |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months. |
| Time to first inappropriate implantable cardioverter-defibrillator (ICD) therapy | From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months. |
| Time to all-cause mortality | From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months. |
| Time to cardiac mortality | From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months. |
| Time to first unplanned all-cause hospitalization | From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months. |
| Time to first unplanned cardiac hospitalization | From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months. |
| Changes in quality of life / mental | This endpoint compares the changes in the mental component score of the Short Form-36 (SF-36) questionnaire from enrollment to the 12-months follow-up. Additionally, descriptive statistics is calculated: absolute scores at enrollment, 3-month follow-up, and 12-month follow-up, short-term changes in scores from enrollment to the 3-month follow-up. | 12 months |
| Changes in quality of life / physical | This endpoint compares the changes in the physical component score of the Short Form-36 (SF-36) questionnaire from enrollment to the 12-months follow-up. Additionally, descriptive statistics is calculated: absolute scores at enrollment, 3-month follow-up, and 12-month follow-up, short-term changes in scores from enrollment to the 3-month follow-up. | 12 months |
| Hamburg |
| 20099 |
| Germany |
| Universitäres Herzzentrum Hamburg | Hamburg | 20246 | Germany |
| Universitätsklinikum Schleswig-Holstein Campus Lübeck | Lübeck | 23538 | Germany |
| Klinikum der Universität München | München | 81377 | Germany |
| Willems S, Tilz RR, Steven D, Kaab S, Wegscheider K, Geller L, Meyer C, Heeger CH, Metzner A, Sinner MF, Schluter M, Nordbeck P, Eckardt L, Bogossian H, Sultan A, Wenzel B, Kuck KH; BERLIN VT Investigators. Preventive or Deferred Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy and Implantable Defibrillator (BERLIN VT): A Multicenter Randomized Trial. Circulation. 2020 Mar 31;141(13):1057-1067. doi: 10.1161/CIRCULATIONAHA.119.043400. Epub 2020 Jan 31. |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |