Heart Failure
Conditions
Keywords
Heart failure (NYHA class III and IV), Ventricular Dyssynchrony
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).
Interventions
DEVICEDevice Implantation
RV apical pacing lead, RV pacing lead at HIS bundle position, LV pacing lead implantation
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement according to Packer's Heart Failure Clinical Composite Respond | 12 months post implant |
Secondary
| Measure | Time frame |
|---|---|
| Cardiopulmonary Capacity(Spiroergometry) | 12 months |
| 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 |
| 12 channel ECG | 12 months |
| 2D-echo optimized EF | 12 months |
| Complications and morbidity | 12 months |
| QoL assessment(Minnesota Living with Heart Failure = MLHF) | 12 months |
Countries
Germany
Outcome results
None listed