Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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)
Information provided by (Responsible Party):
Sven Möbius-Winkler, University of Leipzig Identifier:
First received: July 5, 2006
Last updated: October 25, 2016
Last verified: May 2009

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 Blind (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 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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00348829

Heart Center Leipzig GmbH, University Leipzig
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
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 Identifier: NCT00348829     History of Changes
Other Study ID Numbers: SMW 01
Study First Received: July 5, 2006
Last Updated: October 25, 2016

Keywords provided by University of Leipzig:
mitral insufficiency
conductance catheter
mitral valve repair

Additional relevant MeSH terms:
Heart Failure
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases processed this record on May 22, 2017