Status:
COMPLETED
TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
It's the aim of this study to investigate the impact of Right Ventricular (RV) lead position (RV-apex, His bundle area, RV-apex+His bundle area) in combination with individually optimized Left Ventric...
Eligibility Criteria
Inclusion
- Patient with indication for CRT-D: NYHA III-IV congestive heart failure, in spite of optimal medical treatment for their congestive heart failure
- LVEDD \> 55 mm or \> 30 mm/m² BSA
- EF \< 35%
- Sinus rhythm and one of the following criteria:
- QRS \>= 120 ms and PQ \>= 200ms
- or
- 2nd / 3rd degree AV block
- Written informed consent
Exclusion
- pacemaker indication (without ICD indication)
- tricuspidal valve and/or aortic valve replacement
- Indication for revascularization.
- less than 3 month after heart surgery or myocardial infarction
- hypertrophic obstructive cardiomyopathy
- intravenous catecholamine treatment
- uncorrected thyroid function
- severe kidney disorder (creatinin \>2,5mg%)
- no written patient consent
- insufficient patient compliance
- participating in another study
- life expectancy \< 1 year due to other severe disease
- age \< 18 years
- no contraception (young women) or pregnancy
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00746135
Start Date
November 1 2007
End Date
December 1 2012
Last Update
February 4 2019
Active Locations (1)
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1
Departement of Cardiology - Electrophysiology- Heart Centre Osnabrück - Bad Rothenfelde
Bad Rothenfelde, Germany, 49214