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

Schuechtermann-Klinik

Status and phase: Unknown; Phase 4

Conditions: Left Bundle-Branch Block; Heart Failure

Treatments: Procedure: second LV lead in CRT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01415024

BO/01/2011

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)