New Echocardiographic Parameters for Prediction of Response to Cardiac Resynchronization Therapy

NCT ID: NCT02375399

Last Updated: 2016-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-09-30

Brief Summary

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Echocardiography parameters for cardiac dyssynchrony had no predictive value in current multicentric prospective studies concerning cardiac resynchronization therapy. Comprehensive echocardiography and new parameters as 2D and 3D strain, as well as 3D echo have been analyzed, but their definite value has not been proven yet.

Detailed Description

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In patients with severe heart failure, delays in the conduction system can result in asynchronous contraction impairing cardiac function. By implantation of pacemaker systems with three leads located in atrium, right ventricle and coronary sinus, tracing back this deranged contraction closer to the physiological excitation propagation is aimed (cardial resynchronization therapy \[CRT\]). Despite patient selection according to the guidelines nearly one-third of the patients do not profit, neither clinically nor echocardiographically, from an implanted CRT-device. In addition, recent studies have shown that no reliable prediction may be achieved with the known echocardiographic parameters of dyssynchrony, regarding the response to such therapy. The aim of this study is therefore to assess new echocardiographic parameters, which may allow to better predict CRT response.

Conditions

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Congestive Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* congestive heart failure, dilated cardiomyopathy, indication for implantation of a CRT-device according to the European Society of Cardiology (ESC)

Exclusion Criteria

* persons who are incapable of giving informed consent
* acute heart attack
* arrhythmia during the examination (such as atrial fibrillation and frequent VES)
* state after STEMI with an extended scar
* inotropic drug therapy
* pre-existing permanent pacemaker stimulation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Mathias Konstandin

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mathias Konstandin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

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Department of Cardiology, University of Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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S-553/2012

Identifier Type: -

Identifier Source: org_study_id

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