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

June 30, 2025 updated by: Medtronic Cardiac Rhythm and Heart Failure

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Rothenfelde, Germany
        • Schuechtermann-Kliniken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Procedure: LV dp/dt pressure measurement
Assessment of response to bi-ventricular pacing. Non-esponder-arm, will be treated with standard ICD-treatment
Placebo Comparator: DDD-ICD
Procedure: LV dp/dt pressure measurement
Assessment of response to bi-ventricular pacing. Responder-arm, will be permanently paced bi-ventricularly
Procedure: LV dp/dt pressure measurement
Assessment of response to bi-ventricular pacing. Non-esponder-arm, will be treated with standard ICD-treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Indexed left ventricular volume
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
NYHA-class, 6 minute hallwalk, QOL, BNP-level, echo-criteria
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Collaborators

Medtronic

Investigators

  • Principal Investigator: Guido Luedorff, MD, Schuechtermann-Kliniken

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (Estimated)

January 14, 2009

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

June 30, 2025

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEN_G_CA_10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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