Clinical trial NCT02501005: Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction
Official title: Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ventricular Tachycardia
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2015-07-17
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. History of remote myocardial infarction
2. Left ventricular ejection fraction ≥ 30 to ≤ 50 % as estimated by cardiac MRI, 3D-echocardiography or via ventriculography within 30 days before enrollment
3. Documentation of sustained ventricular tachycardia (VT) by any kind of Electrocardiography (ECG) including 12 lead ECG, holter ECG, rhythm strip, event monitoring, event recorder or pacemaker within 30 days before enrollment
4. Implantable cardioverter-defibrillator (ICD) indication for secondary prevention
5. Patients who are planned to be implanted with BIOTRONIK ICDs (single, dual, triple chamber or DX device)
6. Patient has provided written informed consent
7. Patient accepts activation of Home Monitoring®

Exclusion Criteria:

1. Age \< 18 years or \> 80 years
2. Known arterial or venous thrombosis
3. Class IV New York Heart Association (NYHA) heart failure
4. Valvular heart disease or mechanical heart valve precluding access to the left ventricle
5. Acute myocardial reinfarction or acute coronary syndrome
6. Cardiac surgery involving cardiotomy within the past 2 months
7. Patients requiring chronic renal dialysis
8. Thrombocytopenia or coagulopathy
9. Incessant VT or electrical storm
10. Bundle branch reentry tachycardia as the presenting VT
11. Pre-existing implantable cardioverter-defibrillator (ICD)
12. Pregnancy or breast feeding women
13. Acute illness or active systemic infection
14. Other disease process likely to limit survival to less than 12 months
15. Significant medical problem that in the opinion of the principal investigator would preclude enrollment in the study
16. Unwillingness to participate or lack of availability for follow-up
17. Participation in another interventional clinical investigation during the course of the study, i.e. the participation in a non-interventional clinical investigation is allowed.

Primary outcomes:
measure: 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)
timeFrame: 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.
Secondary outcomes:
measure: Time to first sustained ventricular tachycardia (VT)/ ventricular fibrillation (VF)
timeFrame: 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: Time to first appropriate implantable cardioverter-defibrillator (ICD) therapy
timeFrame: 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: Time to first inappropriate implantable cardioverter-defibrillator (ICD) therapy
timeFrame: 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: Time to all-cause mortality
timeFrame: 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: Time to cardiac mortality
timeFrame: 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: Time to first unplanned all-cause hospitalization
timeFrame: 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: Time to first unplanned cardiac hospitalization
timeFrame: 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: Changes in quality of life / mental
timeFrame: 12 months
measure: Changes in quality of life / physical
timeFrame: 12 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck
city: München
country: Germany
facility: Klinikum der Universität München
Study officials:
affiliation: Asklepios Klinik St. Georg, Hamburg (Germany)
name: Karl-Heinz Kuck, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitäres Herzzentrum, Hamburg (Germany)
name: Stephan Willems, Prof.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.