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

July 4, 2019 updated by: Biotronik SE & Co. KG
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
163

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20099
        • Asklepios Klinik St. Georg
      • Hamburg, Germany, 20246
        • Universitäres Herzzentrum Hamburg
      • Köln, Germany, 50937
        • Universitatsklinikum Koln
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein Campus Lübeck
      • München, Germany, 81377
        • Klinikum der Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group 1 (TG1)
Prophylactic VT ablation prior to ICD implantation
Procedure: VT ablation
Catheter ablation of ventricular tachycardia
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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..
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotronik SE & Co. KG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karl-Heinz Kuck, Prof., Asklepios Klinik St. Georg, Hamburg (Germany)
  • Study Chair: Stephan Willems, Prof., Universitäres Herzzentrum, Hamburg (Germany)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EP028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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