EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty
This study is currently recruiting participants.
Verified March 2013 by Medtronic Bakken Research Center
Sponsor:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01532921
First received: February 10, 2012
Last updated: March 23, 2013
Last verified: March 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 10, 2012 | ||||||||
| Last Updated Date | March 23, 2013 | ||||||||
| Start Date ICMJE | September 2011 | ||||||||
| Estimated Primary Completion Date | March 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Mean Gradient across the TV [ Time Frame: discharge through 6 months post-implant ] [ Designated as safety issue: No ] The mean gradient across the TV measured via echocardiography at discharge through 6 months post-implant |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01532921 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 | EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty | ||||||||
| Official Title ICMJE | EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty | ||||||||
| Brief Summary | Few clinical evidence for the Contour 3D Tricuspid Annuloplasty Ring exists; therefore, in order to position this product on the market, a post-market release study will be completed. The purpose of this study is to evaluate the hemodynamic performance of the Contour 3D® Tricuspid Annuloplasty Ring following Tricuspid Valve repair in a post-market environment. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | The patient population includes all patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve. Patients with primary TV are not included, since this is often characterized by pathological leaflets for which the Contour 3D® Tricuspid Annuloplasty Ring would not be beneficial. |
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| Condition ICMJE | Evaluate the Hemodynamic Performance | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | indicated for a TV repair procedure
all patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve. |
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| 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 | 85 | ||||||||
| Estimated Completion Date | August 2015 | ||||||||
| Estimated Primary Completion Date | March 2015 (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 | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01532921 | ||||||||
| Other Study ID Numbers ICMJE | EASE TRICUSPID | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Medtronic Bakken Research Center | ||||||||
| Study Sponsor ICMJE | Medtronic Bakken Research Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Medtronic Bakken Research Center | ||||||||
| Verification Date | March 2013 | ||||||||
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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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