Mitral Valve Reconstruction in Chronic Heart Failure (CHF): Identification of Predictors for a Successful Therapy

This study has suspended participant recruitment.

(not enough patients to e recruited, problems with the conductance catheter)

Sponsor:

Information provided by:

University of Leipzig

ClinicalTrials.gov Identifier:

NCT00348829

First received: July 5, 2006

Last updated: May 11, 2009

Last verified: May 2009

History of Changes

Purpose

The aim of the study is to evaluate hemodynamic and echocardiographic parameters in patients with secondary mitral insufficiency and CHF.

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

Condition	Intervention	Phase
Chronic Heart Failure Mitral Insufficiency	Procedure: mitral valve repair	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Diagnostic
Official Title:	Mitral Valve Reconstruction in Patients With Chronic Heart Failure and Secondary Mitral Insufficiency: Identification of Predictors for a Successful Therapy

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure Plastic and Cosmetic Surgery

U.S. FDA Resources

Further study details as provided by University of Leipzig:

Primary Outcome Measures:

Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in patients with congestive heart failure [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Identification of clinical factors for the postoperative outcome [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	June 2006
Estimated Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Surgical mitral valve reconstruction	Procedure: mitral valve repair surgical mitral valve repair
No Intervention: 2 conservative treatment

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age > 18 years old
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)
Echocardiographic MI > II°
At least 1 hospitalization for heart failure before 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%
Former valve operation or CABG

Contacts and Locations

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

Locations

Germany
Heart Center Leipzig GmbH, University Leipzig
Leipzig, Germany, 04289

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

No publications provided

Responsible Party:	Dr. Sven Moebius-Winkler, PI, Heart Center Leipzig
ClinicalTrials.gov Identifier:	NCT00348829 History of Changes
Other Study ID Numbers:	SMW 01
Study First Received:	July 5, 2006
Last Updated:	May 11, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:

CHF
mitral insufficiency
conductance catheter
mitral valve repair

Additional relevant MeSH terms:

Heart Failure
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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