Back to resultsPreventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction (BERLIN VT)
Primary Purpose
Ventricular Tachycardia
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
VT ablation
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Tachycardia
Eligibility Criteria
Inclusion Criteria:
- History of remote myocardial infarction
- Left ventricular ejection fraction ≥ 30 to ≤ 50 % as estimated by cardiac MRI, 3D-echocardiography or via ventriculography within 30 days before enrollment
- 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
- Implantable cardioverter-defibrillator (ICD) indication for secondary prevention
- Patients who are planned to be implanted with BIOTRONIK ICDs (single, dual, triple chamber or DX device)
- Patient has provided written informed consent
- Patient accepts activation of Home Monitoring®
Exclusion Criteria:
- Age < 18 years or > 80 years
- Known arterial or venous thrombosis
- Class IV New York Heart Association (NYHA) heart failure
- Valvular heart disease or mechanical heart valve precluding access to the left ventricle
- Acute myocardial reinfarction or acute coronary syndrome
- Cardiac surgery involving cardiotomy within the past 2 months
- Patients requiring chronic renal dialysis
- Thrombocytopenia or coagulopathy
- Incessant VT or electrical storm
- Bundle branch reentry tachycardia as the presenting VT
- Pre-existing implantable cardioverter-defibrillator (ICD)
- Pregnancy or breast feeding women
- Acute illness or active systemic infection
- Other disease process likely to limit survival to less than 12 months
- Significant medical problem that in the opinion of the principal investigator would preclude enrollment in the study
- Unwillingness to participate or lack of availability for follow-up
- Participation in another interventional clinical investigation during the course of the study, i.e. the participation in a non-interventional clinical investigation is allowed.
Sites / Locations
- Asklepios Klinik St. Georg
- Universitäres Herzzentrum Hamburg
- Universitätsklinikum Köln
- Universitätsklinikum Schleswig-Holstein Campus Lübeck
- Klinikum der Universität München
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Treatment Group 1 (TG1)
Treatment Group 2 (TG2)
Arm Description
Prophylactic VT ablation prior to ICD implantation
ICD implantation and best medical care until the third appropriate ICD shock occurs and catheter ablation thereafter
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Time to first sustained ventricular tachycardia (VT)/ ventricular fibrillation (VF)
Time to first appropriate implantable cardioverter-defibrillator (ICD) therapy
Time to first inappropriate implantable cardioverter-defibrillator (ICD) therapy
Time to all-cause mortality
Time to cardiac mortality
Time to first unplanned all-cause hospitalization
Time to first unplanned cardiac hospitalization
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02501005
Brief Title
Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction
Acronym
BERLIN VT
Official Title
Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped due to futility
Study Start Date
July 20, 2015 (Actual)
Primary Completion Date
July 20, 2018 (Actual)
Study Completion Date
July 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik SE & Co. KG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group 1 (TG1)
Arm Type
Experimental
Arm Description
Prophylactic VT ablation prior to ICD implantation
Arm Title
Treatment Group 2 (TG2)
Arm Type
Other
Arm Description
ICD implantation and best medical care until the third appropriate ICD shock occurs and catheter ablation thereafter
Intervention Type
Procedure
Intervention Name(s)
VT ablation
Intervention Description
Catheter ablation of ventricular tachycardia
Primary Outcome Measure Information:
Title
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)
Time Frame
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 Outcome Measure Information:
Title
Time to first sustained ventricular tachycardia (VT)/ ventricular fibrillation (VF)
Time Frame
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..
Title
Time to first appropriate implantable cardioverter-defibrillator (ICD) therapy
Time Frame
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.
Title
Time to first inappropriate implantable cardioverter-defibrillator (ICD) therapy
Time Frame
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.
Title
Time to all-cause mortality
Time Frame
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.
Title
Time to cardiac mortality
Time Frame
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.
Title
Time to first unplanned all-cause hospitalization
Time Frame
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.
Title
Time to first unplanned cardiac hospitalization
Time Frame
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.
Title
Changes in quality of life / mental
Description
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.
Time Frame
12 months
Title
Changes in quality of life / physical
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of remote myocardial infarction
Left ventricular ejection fraction ≥ 30 to ≤ 50 % as estimated by cardiac MRI, 3D-echocardiography or via ventriculography within 30 days before enrollment
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
Implantable cardioverter-defibrillator (ICD) indication for secondary prevention
Patients who are planned to be implanted with BIOTRONIK ICDs (single, dual, triple chamber or DX device)
Patient has provided written informed consent
Patient accepts activation of Home Monitoring®
Exclusion Criteria:
Age < 18 years or > 80 years
Known arterial or venous thrombosis
Class IV New York Heart Association (NYHA) heart failure
Valvular heart disease or mechanical heart valve precluding access to the left ventricle
Acute myocardial reinfarction or acute coronary syndrome
Cardiac surgery involving cardiotomy within the past 2 months
Patients requiring chronic renal dialysis
Thrombocytopenia or coagulopathy
Incessant VT or electrical storm
Bundle branch reentry tachycardia as the presenting VT
Pre-existing implantable cardioverter-defibrillator (ICD)
Pregnancy or breast feeding women
Acute illness or active systemic infection
Other disease process likely to limit survival to less than 12 months
Significant medical problem that in the opinion of the principal investigator would preclude enrollment in the study
Unwillingness to participate or lack of availability for follow-up
Participation in another interventional clinical investigation during the course of the study, i.e. the participation in a non-interventional clinical investigation is allowed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl-Heinz Kuck, Prof.
Organizational Affiliation
Asklepios Klinik St. Georg, Hamburg (Germany)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephan Willems, Prof.
Organizational Affiliation
Universitäres Herzzentrum, Hamburg (Germany)
Official's Role
Study Chair
Facility Information:
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Universitäres Herzzentrum Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitätsklinikum Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein Campus Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Klinikum der Universität München
City
München
ZIP/Postal Code
81377
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
31072848
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.
Results Reference
background
PubMed Identifier
32000514
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.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/31072848
Description
Design Paper
Learn more about this trial
Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction
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