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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Schuechtermann-Klinik.
Recruitment status was:  Recruiting
Information provided by:
Schuechtermann-Klinik Identifier:
First received: July 28, 2011
Last updated: August 10, 2011
Last verified: August 2011

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.

Condition Intervention Phase
Heart Failure Left Bundle-Branch Block Procedure: second LV lead in CRT Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Resynchronization in Paced Heart Failure Patients With ICD Indication

Resource links provided by NLM:

Further study details as provided by Schuechtermann-Klinik:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Leftventricular endsystolic volume [ Time Frame: 12 month ]

Estimated Enrollment: 30
Study Start Date: May 2011
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: second LV lead in CRT
    second LV lead in CRT

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01415024

Contact: Wolfgang Kranig, MD +49-5424-6410
Contact: Rainer Grove, MD +49-5424-6410

Schuechtermann-Klinik Recruiting
Bad Rothenfelde, Niedersachsen, Germany, 49214
Contact: Wolfgang Kranig, MD    +49-5424-6410   
Contact: Rainer Grove, MD    +49-5424-6410   
Sponsors and Collaborators
Principal Investigator: Wolfgang Kranig, MD Schuechtermann-Klinik
  More Information

Responsible Party: Dr. med. Wolfgang Kranig, Schuechtermann- Klinik Identifier: NCT01415024     History of Changes
Other Study ID Numbers: BO/01/2011
Study First Received: July 28, 2011
Last Updated: August 10, 2011

Keywords provided by Schuechtermann-Klinik:
Dual LV
Triple Ventricle stimulation
two leftventricular leads
Av VV optimization
Lv dp/dt measurement

Additional relevant MeSH terms:
Heart Failure
Bundle-Branch Block
Heart Diseases
Cardiovascular Diseases
Heart Block
Arrhythmias, Cardiac
Pathologic Processes processed this record on September 21, 2017