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

This study is currently recruiting participants.
Verified August 2011 by Schuechtermann-Klinik
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
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Resynchronization in Paced Heart Failure Patients With ICD Indication

Resource links provided by NLM:

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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Leftventricular endsystolic volume [ Time Frame: 12 month ] [ Designated as safety issue: No ]

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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. med. Wolfgang Kranig, Schuechtermann- Klinik
ClinicalTrials.gov Identifier: NCT01415024     History of Changes
Other Study ID Numbers: BO/01/2011
Study First Received: July 28, 2011
Last Updated: August 10, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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:
Bundle-Branch Block
Heart Block
Heart Failure
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013