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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2013 by Medtronic Bakken Research Center.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Medtronic Bakken Research Center Identifier:
First received: January 13, 2009
Last updated: January 11, 2013
Last verified: January 2013
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 Intervention Phase
Heart Failure
Procedure: LV dp/dt pressure measurement
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CRT in Patients With Narrow QRS, Echodesynchronisation and LV dp/Dt-Response With Pressure Wire

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Indexed left ventricular volume [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NYHA-class, 6 minute hallwalk, QOL, BNP-level, echo-criteria [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2008
Estimated Study Completion Date: October 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT00821938

Bad Rothenfelde, Germany
Sponsors and Collaborators
Medtronic Bakken Research Center
Principal Investigator: Guido Luedorff, MD Schuechtermann-Kliniken
  More Information

Responsible Party: Medtronic Bakken Research Center Identifier: NCT00821938     History of Changes
Other Study ID Numbers: CEN_G_CA_10 
Study First Received: January 13, 2009
Last Updated: January 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic Bakken Research Center:
Narrow QRS
CRT processed this record on April 27, 2016