NCT00746135
Completed
Not Applicable
TRI-V Resynchronization in Paced Heart Failure Patients With ICD Indication.
ConditionsHeart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Abbott Medical Devices
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Improvement according to Packer's "Heart Failure Clinical Composite Respond"
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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).
Investigators
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Improvement according to Packer's "Heart Failure Clinical Composite Respond"
Time Frame: 12 months post implant
Secondary Outcomes
- Change in B-type natriuretic Peptide (BNP)-Concentration(12 months)
- 6 min walk test(12 months)
- 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)
- 12 channel ECG(12 months)
- Complications and morbidity(12 months)
Study Sites (1)
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