TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) Study

Study Overview
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Brief Summary
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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).

Official Title
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TRI-V Resynchronization in Paced Heart Failure Patients With ICD Indication.

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Device Implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Conventional Biventricular Stimulation: RV Apex and LV Lead Tip | Device: Device Implantation<br>* RV apical pacing lead, RV pacing lead at HIS bundle position, LV pacing lead implantation<br>* Other names: VIS 16 / Dr. Osypka GmbH;|
| Active Comparator: B<br>Anodal-Cathodal Biventricular Stimulation: cathodal LV Stimulation und anodal RVHis Stimulation = Anodal-cathodal Bi-V. | Device: Device Implantation<br>* RV apical pacing lead, RV pacing lead at HIS bundle position, LV pacing lead implantation<br>* Other names: VIS 16 / Dr. Osypka GmbH;|
| Active Comparator: C<br>Anodal-Cathodal Tri-V Stimulation: RV-apex and LV and RV-His | Device: Device Implantation<br>* RV apical pacing lead, RV pacing lead at HIS bundle position, LV pacing lead implantation<br>* Other names: VIS 16 / Dr. Osypka GmbH;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement according to Packer's Heart Failure Clinical Composite Respond |  | 12 months post implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Increase in Left Ventricular dp/dt |  | At Implant | 
| Cardiopulmonary Capacity(Spiroergometry) |  | 12 months | 
| Change in B-type natriuretic Peptide (BNP)-Concentration |  | 12 months | 
| 6 min walk test |  | 12 months | 
| QoL assessment(Minnesota Living with Heart Failure = MLHF) |  | 12 months | 
| 12 channel ECG |  | 12 months | 
| 2D-echo optimized EF |  | 12 months | 
| Complications and morbidity |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure (NYHA class III and IV), Ventricular Dyssynchrony