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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 27 August 2018
Main ID:  NCT02501005
Date of registration: 06/07/2015
Prospective Registration: Yes
Primary sponsor: Biotronik SE & Co. KG
Public title: Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction BERLIN VT
Scientific title: Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction
Date of first enrolment: July 20, 2015
Target sample size: 163
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT02501005
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Germany
Contacts
Name:     Karl-Heinz Kuck, Prof.
Address: 
Telephone:
Email:
Affiliation:  Asklepios Klinik St. Georg, Hamburg (Germany)
Name:     Stephan Willems, Prof.
Address: 
Telephone:
Email:
Affiliation:  Universitäres Herzzentrum, Hamburg (Germany)
Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Ventricular Tachycardia
Intervention(s)
Procedure: VT ablation
Primary Outcome(s)
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.]
Secondary Outcome(s)
Changes in quality of life / mental [Time Frame: 12 months]
Changes in quality of life / physical [Time Frame: 12 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.]
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.]
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.]
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.]
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..]
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.]
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.]
Secondary ID(s)
EP028
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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