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

This study has been terminated.
(not enough patients to e recruited, problems with the conductance catheter)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00348829
First Posted: July 6, 2006
Last Update Posted: October 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sven Möbius-Winkler, University of Leipzig
  Purpose

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

  1. Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in CHF patients.
  2. 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 (Participant, 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:


Further study details as provided by Sven Möbius-Winkler, 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 ]

Secondary Outcome Measures:
  • Identification of clinical factors for the postoperative outcome [ Time Frame: 3 months ]

Enrollment: 5
Study Start Date: June 2006
Study Completion Date: September 2012
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18 years old
  2. Dilatative Cardiomyopathy with LVEF < 35%
  3. NYHA III oder IV under maximal medical treatment
  4. Angiographic and hemodynamic MI > II° (LAP- mean pressure > 15-20 mmHg; LA v-wave-oder PCWP v-wave > 35 mmHg under exercise)
  5. Echocardiographic MI > II°
  6. At least 1 hospitalization for heart failure before OP

Exclusion Criteria:

  1. Secondary Cardiomyopathy by vitium cordis
  2. Planned secondary procedure like CABG, aortic valve surgery, surgery of the tricuspid valve etc
  3. Inclusion in another trial
  4. Euro-Score > 30%
  5. Former valve operation or CABG
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sven Möbius-Winkler, PD Dr. med., University of Leipzig
ClinicalTrials.gov Identifier: NCT00348829     History of Changes
Other Study ID Numbers: SMW 01
First Submitted: July 5, 2006
First Posted: July 6, 2006
Last Update Posted: October 27, 2016
Last Verified: May 2009

Keywords provided by Sven Möbius-Winkler, 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