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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01415024
Recruitment Status : Unknown
Verified August 2011 by Schuechtermann-Klinik.
Recruitment status was:  Recruiting
First Posted : August 11, 2011
Last Update Posted : August 11, 2011
Information provided by:

July 28, 2011
August 11, 2011
August 11, 2011
May 2011
May 2012   (Final data collection date for primary outcome measure)
LV dp/dt pressure during dual LV CRT stimulation vs. conventional biventricular pacing [ Time Frame: Implantation with pressure measurement will take place in the first week ]
Same as current
No Changes Posted
Leftventricular endsystolic volume [ Time Frame: 12 month ]
Same as current
Not Provided
Not Provided
Resynchronization in Paced Heart Failure Patients With Implantable Cardioverter Defibrillator (ICD) Indication
Resynchronization in Paced Heart Failure Patients With ICD Indication

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.

Not Provided
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Heart Failure
  • Left Bundle-Branch Block
Procedure: second LV lead in CRT
second LV lead in CRT
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
Not Provided
May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Dr. med. Wolfgang Kranig, Schuechtermann- Klinik
Principal Investigator: Wolfgang Kranig, MD Schuechtermann-Klinik
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP