TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) Study
NCT ID: NCT00746135
Last Updated: 2019-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2007-11-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A
Conventional Biventricular Stimulation: RV Apex and LV Lead Tip
Device Implantation
RV apical pacing lead, RV pacing lead at HIS bundle position, LV pacing lead implantation
B
Anodal-Cathodal Biventricular Stimulation: cathodal LV Stimulation und anodal RVHis Stimulation = "Anodal-cathodal Bi-V".
Device Implantation
RV apical pacing lead, RV pacing lead at HIS bundle position, LV pacing lead implantation
C
Anodal-Cathodal Tri-V Stimulation: RV-apex and LV and RV-His
Device Implantation
RV apical pacing lead, RV pacing lead at HIS bundle position, LV pacing lead implantation
Interventions
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Device Implantation
RV apical pacing lead, RV pacing lead at HIS bundle position, LV pacing lead implantation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Wolfgang Kranig, MD
Role: PRINCIPAL_INVESTIGATOR
Departement of Cardiology - Electrophysiology- Heart Centre Osnabrück - Bad Rothenfelde
Locations
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Departement of Cardiology - Electrophysiology- Heart Centre Osnabrück - Bad Rothenfelde
Bad Rothenfelde, , Germany
Countries
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Other Identifiers
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H37
Identifier Type: -
Identifier Source: org_study_id
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