Mitral Valve Reconstruction in Chronic Heart Failure (CHF): Identification of Predictors for a Successful Therapy
NCT ID: NCT00348829
Last Updated: 2016-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
5 participants
INTERVENTIONAL
2006-06-30
2012-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Surgical mitral valve reconstruction
mitral valve repair
surgical mitral valve repair
2
conservative treatment
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
mitral valve repair
surgical mitral valve repair
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Leipzig
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sven Möbius-Winkler
PD Dr. med.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gerhard Schuler, Prof.
Role: STUDY_CHAIR
Chair of the Dep. of Cardiology
Sven Möbius-Winkler, MD
Role: PRINCIPAL_INVESTIGATOR
Consultant of the dep. of Cardiology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Heart Center Leipzig GmbH, University Leipzig
Leipzig, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SMW 01
Identifier Type: -
Identifier Source: org_study_id