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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
  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 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:


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:

  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 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
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on November 25, 2014