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Completed

NCT Number: NCT00821938

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

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Schuechtermann-Kliniken

Bad Rothenfelde, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LV dp/dt pressure measurement

Procedure

Assessment of response to bi-ventricular pacing. Responder-arm, will be permanently paced bi-ventricularly

Primary outcomes

  1. Indexed left ventricular volume

    Time frame: 12 months

Secondary outcomes

  1. NYHA-class, 6 minute hallwalk, QOL, BNP-level, echo-criteria

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: CRT-Narrow

Important dates

Study start
2008
Primary completion
2012
Study completion
2016
First posted
Jan 14, 2009
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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