Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction

Not Applicable

Terminated

• Conditions: Ventricular Tachycardia
• Interventions: Procedure: VT ablation

• Registration Number: NCT02501005
• Lead Sponsor: Biotronik SE & Co. KG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-06
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-17
• Study Start: 2015-07-20
• Primary Completion: 2018-07-20
• Study Completion: 2018-07-20
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-04
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 163

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group 1 (TG1)	VT ablation	Prophylactic VT ablation prior to ICD implantation
Treatment Group 2 (TG2)	VT ablation	ICD implantation and best medical care until the third appropriate ICD shock occurs and catheter ablation thereafter

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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.
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 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.
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.
Changes in quality of life / mental	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.
Changes in quality of life / physical	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.
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 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.

Trial Locations

Locations (5)

Universitäres Herzzentrum Hamburg; 🇩🇪 Hamburg, Germany

Klinikum der Universität München; 🇩🇪 München, Germany

Asklepios Klinik St. Georg; 🇩🇪 Hamburg, Germany

Universitätsklinikum Köln; 🇩🇪 Köln, Germany

Universitätsklinikum Schleswig-Holstein Campus Lübeck; 🇩🇪 Lübeck, Germany