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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.
ClinicalTrials.gov 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
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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.


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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : May 2011
Estimated Primary Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Procedure: second LV lead in CRT
    second LV lead in CRT

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Leftventricular endsystolic volume [ Time Frame: 12 month ]

Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415024


Contacts
Contact: Wolfgang Kranig, MD +49-5424-6410 wkranig@schuechtermann-klinik.de
Contact: Rainer Grove, MD +49-5424-6410 rgrove@schuechtermann-klinik.de

Locations
Germany
Schuechtermann-Klinik Recruiting
Bad Rothenfelde, Niedersachsen, Germany, 49214
Contact: Wolfgang Kranig, MD    +49-5424-6410    wkranig@schuechtermann-klinik.de   
Contact: Rainer Grove, MD    +49-5424-6410    rgrove@schuechtermann-klinik.de   
Sponsors and Collaborators
Schuechtermann-Klinik
Medtronic
Investigators
Principal Investigator: Wolfgang Kranig, MD Schuechtermann-Klinik
More Information

Responsible Party: Dr. med. Wolfgang Kranig, Schuechtermann- Klinik
ClinicalTrials.gov Identifier: NCT01415024     History of Changes
Other Study ID Numbers: BO/01/2011
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: August 11, 2011
Last Verified: August 2011

Keywords provided by Schuechtermann-Klinik:
CRT
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