Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction (BERLIN VT)

• ClinicalTrials.gov Identifier: NCT02501005
• Recruitment Status: Terminated
• First Posted: July 17, 2015
• Last Update Posted: July 8, 2019
• Sponsor: Biotronik SE & Co. KG
• Information provided by (Responsible Party): Biotronik SE & Co. KG

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.

Condition or disease	Intervention/treatment	Phase
Ventricular Tachycardia	Procedure: VT ablation	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 163 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction
• Actual Study Start Date: July 20, 2015
• Actual Primary Completion Date: July 20, 2018
• Actual Study Completion Date: July 20, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment Group 1 (TG1); Prophylactic VT ablation prior to ICD implantation	Procedure: VT ablation; Catheter ablation of ventricular tachycardia
Treatment Group 2 (TG2); ICD implantation and best medical care until the third appropriate ICD shock occurs and catheter ablation thereafter	Procedure: VT ablation; Catheter ablation of ventricular tachycardia

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. 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.. ]
2. 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. ]
3. 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. ]
4. 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. ]
5. 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. ]
6. 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. ]
7. 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. ]
8. Changes in quality of life / mental [ Time Frame: 12 months ]
   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.
9. Changes in quality of life / physical [ Time Frame: 12 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Germany

Asklepios Klinik St. Georg

Hamburg, Germany, 20099

Universitäres Herzzentrum Hamburg

Hamburg, Germany, 20246

Universitätsklinikum Köln

Köln, Germany, 50937

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, Germany, 23538

Klinikum der Universität München

München, Germany, 81377

Sponsors and Collaborators

Biotronik SE & Co. KG

Investigators

• Principal Investigator: Karl-Heinz Kuck, Prof.; Asklepios Klinik St. Georg, Hamburg (Germany)
• Study Chair: Stephan Willems, Prof.; Universitäres Herzzentrum, Hamburg (Germany)

More Information

Additional Information:

Design Paper 

Publications:

Tilz RR, Kuck KH, Kääb 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Willems S, Tilz RR, Steven D, Kääb S, Wegscheider K, Gellér L, Meyer C, Heeger CH, Metzner A, Sinner MF, Schlüter 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.

• Responsible Party: Biotronik SE & Co. KG
• ClinicalTrials.gov Identifier: NCT02501005
• Other Study ID Numbers: EP028
• First Posted: July 17, 2015
• Last Update Posted: July 8, 2019
• Last Verified: July 2019

Additional relevant MeSH terms:

Myocardial Infarction; Tachycardia; Tachycardia, Ventricular; Infarction; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease