Predictors of Postoperative Left Ventricular Function in Patients Undergoing Mitral Valve Repair for Severe Degenerative Mitral Regurgitation
This study is currently recruiting participants.
Verified January 2012 by University of Zurich
Sponsor:
University of Zurich
Collaborator:
Valtech Cardio Ltd
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01519050
First received: January 23, 2012
Last updated: January 25, 2012
Last verified: January 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 23, 2012 | ||||||||
| Last Updated Date | January 25, 2012 | ||||||||
| Start Date ICMJE | November 2011 | ||||||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01519050 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Predictors of Postoperative Left Ventricular Function in Patients Undergoing Mitral Valve Repair for Severe Degenerative Mitral Regurgitation | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| Brief Summary | The aim of the study is to investigate whether a predictive score (combination of several validated predictors) better predicts postoperative left ventricular function than any single predictor in patients undergoing mitral valve repair for degenerative mitral regurgitation. A single center, prospective cohort study |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | 100 patients with mitral valve proplapse ondergoing mitral valve repair for severe mitral regurgitation |
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| Condition ICMJE | Severe Degenerative Mitral Regurgitation | ||||||||
| Intervention ICMJE | Behavioral: mitral valve repair
Mitral valve repair in patients with degenerative mitral regurgitation |
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| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | May 2014 | ||||||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Switzerland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01519050 | ||||||||
| Other Study ID Numbers ICMJE | KEK ZH 2011- 0274 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | University of Zurich | ||||||||
| Study Sponsor ICMJE | University of Zurich | ||||||||
| Collaborators ICMJE | Valtech Cardio Ltd | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Zurich | ||||||||
| Verification Date | January 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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