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Cardiac Resynchronization Therapy (CRT)-Narrow-dp/Dt-Study (CRT-Narrow)

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: NCT00821938
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : November 25, 2016
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center

Study Description
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Brief Summary:
Goal is to examine the efficy of Cardiac Resynchronization Therapy in heart failure patients with narrow QRS complex and optimized medical treatment but echocardiographic desynchronization detection as well as the positve increase of the intraoperative pressureincreasespeed in reverse remodelling and a secondary improvement of functional parameters

Condition or disease Intervention/treatment Phase
Heart Failure Procedure: LV dp/dt pressure measurement Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CRT in Patients With Narrow QRS, Echodesynchronisation and LV dp/Dt-Response With Pressure Wire
Study Start Date : November 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CRT-ICD Procedure: LV dp/dt pressure measurement
Assessment of response to bi-ventricular pacing. Responder-arm, will be permanently paced bi-ventricularly
Placebo Comparator: DDD-ICD Procedure: LV dp/dt pressure measurement
Assessment of response to bi-ventricular pacing. Non-esponder-arm, will be treated with standard ICD-treatment


Outcome Measures
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Primary Outcome Measures :
  1. Indexed left ventricular volume [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. NYHA-class, 6 minute hallwalk, QOL, BNP-level, echo-criteria [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • EF < 35%
  • CHD or dilate cardiomyopathy
  • sinus rhythm
  • NYHA III (or IV but stable recompenstated)
  • QRS < 120 ms 2-3 of the following:
  • LV-fillingtime < 40% of the cyclelength
  • TDI septal-lateral (LV basal) > 60ms
  • 2D-Strain-Score > 9 points

Exclusion Criteria:

  • tricuspid or artificial valve
  • AV block II or III or PQ time > 250ms
  • revasculisation or condition after cardiac surgery < 3 months
  • myocardial infarction or bypass OP < 3 months
  • hytertrphic obstructive cardiomyopathy, constrictive pericarditis
  • intravenous catecholamines because of HF
  • manifeste hyperthyreoses
  • kidney failure (creatine >2,5 mg/dl)
  • no written informed consent
  • no compliance
  • participation in another study
  • life expectancy < 1 year
  • patients < 18 years
  • pragnancy or no safe contraception
Contacts and Locations
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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): NCT00821938


Locations
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Germany
Schuechtermann-Kliniken
Bad Rothenfelde, Germany
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
Investigators
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Principal Investigator: Guido Luedorff, MD Schuechtermann-Kliniken
More Information
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Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00821938    
Other Study ID Numbers: CEN_G_CA_10
First Posted: January 14, 2009    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016
Keywords provided by Medtronic Bakken Research Center:
Narrow QRS
CRT
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases