Mitral Valve Reconstruction in CHF: Identifikation of Predictors for a Successful Therapy

This study is currently recruiting participants.

Verified by University of Leipzig, June 2006

Sponsored by:	University of Leipzig
Information provided by:	University of Leipzig
ClinicalTrials.gov Identifier:	NCT00348829

Purpose

Aim of the study is to evaluate hemodynamic and echocardiographic parameters in patients with secondary mitral insuffizienc and CHF.

Identifikation of hemodynamic parameters as predictor for a successful mitral valve reconstruction in CHF patients.
Collection of clinical factors for the assesement of the postoperative course after mitral valve reconstruction in chf patient.

Condition	Intervention	Phase
Chronic Heart Failure Mitral Insufficiency	Procedure: Mitral valve reconstruction	Phase II

MedlinePlus related topics: Heart Failure

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:	Mitral Valve Reconstruction in Patients With Chronic Heart Failure and Secondary Mitral Insufficiency: Identifikation of Predictors for a Successful Therapy

Further study details as provided by University of Leipzig:

Primary Outcome Measures:

Identifikation of hemodynamic parameters as prediktor for a successful mitral valve reconstruction in Pts. with CHF.

Secondary Outcome Measures:

Estimated Enrollment:	20
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2006

Eligibility

Criteria

Inclusion Criteria:

Age > 18 Jahre
dilatative Cardiomyopathy with LVEF < 35%.
NYHA III oder IV under maximal medical treatment
angiographic and hemodynamic MI > II° (LAP- mean pressure > 15-20 mmHg; LA v-wave- oder PCWP v-wave > 35 mmHg under exercise)
Echokardiographic MI > II°
at least 1 haospitalisation for heart failurebefore OP

Exclusion Criteria:

secondary Cardiomyopathy by vitium cordis.
Planned secondary procedure like CABG, aortic valve surgery, surgery of the tricuspid valve etc..
Inclusion in another trial
Euro-Score > 30%

6. Former valve operation or CABG

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348829

Contacts

Contact: Sven Möbius-Winkler, MD	0049-341-865-1428	moes@medizin.uni-leipzig.de
Contact: Claudia Walther, MD	0049-341-865-1428	cwalthe@medizin.uni-leipzig.de

Locations

Germany
Heart Center Leipzig GmbH, University Leipzig	Recruiting
Leipzig, Germany, 04289
Contact: Sven Möbius-Winkler, MD 0049-341-865-1428 moes@medizin.uni-leipzig.de

Sponsors and Collaborators

University of Leipzig

Investigators

Study Chair:	Gerhard Schuler, Prof.	Chair of the Dep. of Cardiology
Principal Investigator:	Sven Möbius-Winkler, MD	Consultant of the dep. of Cardiology

More Information

Study ID Numbers:	SMW 01
Study First Received:	July 5, 2006
Last Updated:	July 5, 2006
ClinicalTrials.gov Identifier:	NCT00348829
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:

CHF,
mitral insufficiency,
conductance catheter,
mitral valve repair

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Neoplasm Metastasis
Heart Valve Diseases
Mitral Valve Insufficiency

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009