Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction

Ventricular Tachycardia Clinical Trial

— BERLIN VT  

Official title:

Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02501005
• Other study ID #: EP028
• Status: Terminated
• Phase: N/A
• Start date: July 20, 2015
• Est. completion date: July 20, 2018

Study information

• Verified date: July 2019
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 163
• Est. completion date: July 20, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Procedure:
• VT ablation
Catheter ablation of ventricular tachycardia

Locations

Country	Name	City	State
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Universitäres Herzzentrum Hamburg	Hamburg
Germany	Universitätsklinikum Köln	Köln
Germany	Universitätsklinikum Schleswig-Holstein Campus Lübeck	Lübeck
Germany	Klinikum der Universität München	München

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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..
Secondary	Time to first appropriate 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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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

External Links

•   Design Paper