This trial is active, not recruiting.

Condition heart failure
Treatments lv dp/dt pressure measurement
Phase phase 4
Sponsor Medtronic Bakken Research Center
Collaborator Medtronic
Start date November 2008
End date August 2012
Trial size 60 participants
Trial identifier NCT00821938, CEN_G_CA_10


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
lv dp/dt pressure measurement
Assessment of response to bi-ventricular pacing. Responder-arm, will be permanently paced bi-ventricularly
(Placebo Comparator)
lv dp/dt pressure measurement
Assessment of response to bi-ventricular pacing. Non-esponder-arm, will be treated with standard ICD-treatment

Primary Outcomes

Indexed left ventricular volume
time frame: 12 months

Secondary Outcomes

NYHA-class, 6 minute hallwalk, QOL, BNP-level, echo-criteria
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title CRT in Patients With Narrow QRS, Echodesynchronisation and LV dp/Dt-Response With Pressure Wire
Principal investigator Guido Luedorff, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Medtronic Bakken Research Center.