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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Schuechtermann-Klinik.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Medtronic
Information provided by:
Schuechtermann-Klinik
ClinicalTrials.gov Identifier:
NCT01415024
First received: July 28, 2011
Last updated: August 10, 2011
Last verified: August 2011

July 28, 2011
August 10, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01415024 on ClinicalTrials.gov Archive Site
Leftventricular endsystolic volume [ Time Frame: 12 month ] [ Designated as safety issue: No ]
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
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
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
Both
18 Years to 80 Years
No
Contact: Wolfgang Kranig, MD +49-5424-6410 wkranig@schuechtermann-klinik.de
Contact: Rainer Grove, MD +49-5424-6410 rgrove@schuechtermann-klinik.de
Germany
 
NCT01415024
BO/01/2011
No
Dr. med. Wolfgang Kranig, Schuechtermann- Klinik
Schuechtermann-Klinik
Medtronic
Principal Investigator: Wolfgang Kranig, MD Schuechtermann-Klinik
Schuechtermann-Klinik
August 2011

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