Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction

NCT02501005 | Terminated DMC

• 1 other identifier: EP028
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 5

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.

Conditions

Ventricular Tachycardia

Outcome Measures

Primary Outcomes (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)

  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 (9)

• 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 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 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 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.

• 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.

Study Arms (2)

Treatment Group 1 (TG1)

EXPERIMENTAL

Prophylactic VT ablation prior to ICD implantation

Procedure: VT ablation

Treatment Group 2 (TG2)

OTHER

ICD implantation and best medical care until the third appropriate ICD shock occurs and catheter ablation thereafter

Procedure: VT ablation

Interventions

VT ablation PROCEDURE

Catheter ablation of ventricular tachycardia

Treatment Group 1 (TG1); Treatment Group 2 (TG2)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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®

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (5)

Universitätsklinikum Köln

Cologne, 50937, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

Universitäres Herzzentrum Hamburg

Hamburg, 20246, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, 23538, Germany

Location

Klinikum der Universität München

München, 81377, Germany

Location

Related Publications (2)

• 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.

  PMID: 31072848 BACKGROUND

• 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.

  PMID: 32000514 DERIVED

Related Links

• Design Paper

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karl-Heinz Kuck, Prof.

  Asklepios Klinik St. Georg, Hamburg (Germany)

  PRINCIPAL INVESTIGATOR

• Stephan Willems, Prof.

  Universitäres Herzzentrum, Hamburg (Germany)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 17, 2015
• Study Start: July 20, 2015
• Primary Completion: July 20, 2018
• Study Completion: July 20, 2018
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

DE (5)