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Ventricular TachycardiaBERLIN VTNCT02501005

Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction

A study testing VT ablation in people with Ventricular Tachycardia, run by Biotronik SE & Co. KG at 5 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ventricular Tachycardia
What is being tested?
VT ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
163 participants
Where
5 sitesGermany
Study dates
20 Jul 2015to 20 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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®

Who cannot join

  • 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
Show all 17Show fewer
  • 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
  • Unwillingness to participate or lack of availability for follow-up
  • Participation in another interventional clinical investigation during the course of the study, i.e. the participation in a non-interventional clinical investigation is allowed.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • Universitätsklinikum Köln

    Cologne, 50937

  • Asklepios Klinik St. Georg

    Hamburg, 20099

  • Universitäres Herzzentrum Hamburg

    Hamburg, 20246

  • Universitätsklinikum Schleswig-Holstein Campus Lübeck

    Lübeck, 23538

  • Klinikum der Universität München

    München, 81377

Other trials in Germany

About this study

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.

Being tested
VT ablation
Medical subject headings
Tachycardia, Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VT ablationProcedure or surgery

    Catheter ablation of ventricular tachycardia

Study groups in NCT02501005
Study groupRoleWhat they receive
Treatment Group 1 (TG1)ExperimentalProphylactic VT ablation prior to ICD implantation
Receives: Procedure: VT ablation
Treatment Group 2 (TG2)OtherICD implantation and best medical care until the third appropriate ICD shock occurs and catheter ablation thereafter
Receives: Procedure: VT ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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)

  1. Time to first sustained ventricular tachycardia (VT)/ ventricular fibrillation (VF)

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    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.

    Measured: 12 months

  9. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2015 (estimated)
  2. Study start20 Jul 2015
  3. Primary completion20 Jul 2018
  4. Study completion20 Jul 2018

Why it stopped: The study was stopped due to futility

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02501005
Sponsor's protocol ID
EP028
Acronym
BERLIN VT
Status last verified
Jul 2019
First submitted
6 Jul 2015
Last updated
8 Jul 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31072848

  • 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.

    PubMed 32000514

Questions about this trial

What is this clinical trial studying?

A study testing VT ablation in people with Ventricular Tachycardia, run by Biotronik SE & Co. KG at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The study was stopped due to futility). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02501005, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.

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