Resynchronization in Paced Heart Failure Patients With Implantable Cardioverter Defibrillator (ICD) Indication

Study Overview
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Brief Summary
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Today patients with a Cardiac Resynchronization Therapy (CRT) indication usually receive 2 ventricular leads, right ventricular (RV) apex and left ventricular (LV) (postero-) lateral, gaining a responder rate of approximately 70%. However, the physiological agitation of the left ventricle takes place over two pathways. Therefore single point stimulation might be insufficient for a dilated, insufficiently and asynchronously contracting left ventricle, resulting in either insufficient or no response to the therapy. In the CRT ICD Dual LV study the patients receive a second LV lead in an anterior vein. When this lead is placed, temporary dual LV stimulation is started. To assess the effectivity of the dual LV lead stimulation intraoperatively a LV dp/dt-pressure measurement is taken. If there is an increase in LV dp/dt, the patients will be stimulated with both leads permanently. If not they will be stimulated conventionally. The patients participating in this study are monitored for 12 months after implantation.

Official Title
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Resynchronization in Paced Heart Failure Patients With ICD Indication

Conditions
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Heart Failure, Left Bundle-Branch Block

Intervention / Treatment
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* Procedure: second LV lead in CRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: EF less than 35 percent CAD or dilatative Cardiomyopathy Sinus rhythm NYHA III or IV, stable recompensated QRS more than 120ms LBBB Patient signed Consent Form Age more than 18 and less than 80 y Exclusion Criteria: permanent atrial Fibrillation permanent AV-Block II or III Tricuspidal- and or artificial aortic valve Indication for ACB or ACB less than 3 months ago myocardial infarction less than 3 months hypertrophic obstructive Cardiomyopathy; constrictive Pericarditis heartfailure with iv catecholamine therapy Manifested, uncontrolled, Hypo- oder Hyperthyreosis Severe renal insufficiency with Creatinine more than 2,5 mg per dL patients, who did not sign the consent form General medical conditions, which restrict the patient compliance Participation in another study life expectancy less than 1 y Age less than 18 y or more than 80y Pregnant women or Women of childbearing age

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: second LV lead in CRT|second LV lead in CRT|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LV dp/dt pressure during dual LV CRT stimulation vs. conventional biventricular pacing |  | Implantation with pressure measurement will take place in the first week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leftventricular endsystolic volume |  | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRT, Dual LV, Triple Ventricle stimulation, two leftventricular leads, Av VV optimization, Lv dp/dt measurement