TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) Study
Not Applicable
Completed
- Conditions
- Heart Failure
- Registration Number
- NCT00746135
- Lead Sponsor
- Abbott Medical Devices
- 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 Ventricular (LV) lead placement and CRT timing on the outcome of cardiac resynchronization therapy (CRT).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Improvement according to Packer's "Heart Failure Clinical Composite Respond" 12 months post implant
- Secondary Outcome Measures
Name Time Method Intraoperative Increase in Left Ventricular dp/dt At Implant QoL assessment("Minnesota Living with Heart Failure = MLHF) 12 months Cardiopulmonary Capacity(Spiroergometry) 12 months 2D-echo optimized EF 12 months Change in B-type natriuretic Peptide (BNP)-Concentration 12 months 6 min walk test 12 months 12 channel ECG 12 months Complications and morbidity 12 months
Trial Locations
- Locations (1)
Departement of Cardiology - Electrophysiology- Heart Centre Osnabrück - Bad Rothenfelde
🇩🇪Bad Rothenfelde, Germany
Departement of Cardiology - Electrophysiology- Heart Centre Osnabrück - Bad Rothenfelde🇩🇪Bad Rothenfelde, Germany