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Clinical Trials/NCT00821938
NCT00821938CompletedPhase 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 enrollmentStarted: November 1, 2008Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Indexed left ventricular volume
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
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

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)

Investigators

Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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