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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00821938
First received: January 13, 2009
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

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

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00821938

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

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov 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

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 22, 2014