Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00821938
NCT00821938
Completed
Phase 4

CRT in Patients With Narrow QRS, Echodesynchronisation and LV dp/Dt-Response With Pressure Wire

Medtronic Cardiac Rhythm and Heart Failure1 site in 1 country30 target enrollmentNovember 1, 2008
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHeart Failure

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Enrollment
30
Locations
1
Primary Endpoint
Indexed left ventricular volume
Status
Completed
Last Updated
10 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
November 1, 2008
End Date
July 1, 2016
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Indexed left ventricular volume

Time Frame: 12 months

Secondary Outcomes

  • NYHA-class, 6 minute hallwalk, QOL, BNP-level, echo-criteria(12 months)

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 2
Cardiac Resynchronization Therapy in Congenital Heart DefectsCongenital Heart Defects
NCT00450684Competence Network for Congenital Heart Defects55
Completed
Not Applicable
Cardiac Resynchronisation Therapy and AV Nodal Ablation Trial in Atrial Fibrillation Patients (CAAN-AF)Heart FailureAtrial Fibrillation
NCT01522898University of Adelaide145
Unknown
Not Applicable
Assessment of Cardiac Resynchronization Therapy in Patients With Wide QRS and Non-specific Intraventricular Conduction Delay: a Randomized TrialHeart Failure
NCT02454439University Hospital, Clermont-Ferrand200
Terminated
Not Applicable
Scar Location and Acute Haemodynamic Response to MultiPoint Pacing Study in Patients With Ischemic CardiomyopathyHeart FailureIschemic Cardiomyopathy
NCT04066738Oxford University Hospitals NHS Trust2
Terminated
Not Applicable
Re-evaluation of Optimal Re-synchronisation Therapy in Patients With Chronic Heart FailureChronic Heart Failure
NCT03494933Helios Health Institute GmbH959