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

Heart Failure Clinical Trial

— CRTICD Dual LV  

Official title:

Resynchronization in Paced Heart Failure Patients With ICD Indication

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01415024
• Other study ID #: BO/01/2011
• Status: Recruiting
• Phase: Phase 4
• First received: July 28, 2011
• Last updated: August 10, 2011
• Start date: May 2011

Study information

• Verified date: August 2011
• Source: Schuechtermann-Klinik
• Contact: Wolfgang Kranig, MD
• Phone: +49-5424-6410
• Email: wkranig[@]schuechtermann-klinik.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bundle-Branch Block
• Heart Failure
• Left Bundle-Branch Block

Intervention

Procedure:
• second LV lead in CRT
second LV lead in CRT

Locations

Country	Name	City	State
Germany	Schuechtermann-Klinik	Bad Rothenfelde	Niedersachsen

Sponsors (2)

Lead Sponsor	Collaborator
Schuechtermann-Klinik	Medtronic

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LV dp/dt pressure during dual LV CRT stimulation vs. conventional biventricular pacing		Implantation with pressure measurement will take place in the first week	No
Secondary	Leftventricular endsystolic volume		12 month	No