Trial record 1 of 1 for:
SUMMIT Tendyne
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT)
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| ClinicalTrials.gov Identifier: NCT03433274 |
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Recruitment Status :
Recruiting
First Posted : February 14, 2018
Last Update Posted : June 15, 2022
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Sponsor:
Abbott Medical Devices
Information provided by (Responsible Party):
Abbott Medical Devices
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | February 8, 2018 | |||||||||
| First Posted Date ICMJE | February 14, 2018 | |||||||||
| Last Update Posted Date | June 15, 2022 | |||||||||
| Actual Study Start Date ICMJE | June 15, 2018 | |||||||||
| Estimated Primary Completion Date | June 2023 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Not Provided | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation | |||||||||
| Official Title ICMJE | Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation | |||||||||
| Brief Summary | Prospective, controlled, multicenter clinical investigation with three trial cohorts: Randomized, Non-repairable, and Severe Mitral Annular Calcification (MAC). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-repairable and Severe MAC cohorts will receive the trial device. The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification. This randomized controlled trial will provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-repairable cohort. Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years. |
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| Detailed Description | Not Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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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 |
958 | |||||||||
| Original Enrollment ICMJE | Not Provided | |||||||||
| Estimated Study Completion Date ICMJE | June 2027 | |||||||||
| Estimated Primary Completion Date | June 2023 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Canada, United States | |||||||||
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| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT03433274 | |||||||||
| Other Study ID Numbers ICMJE | CS0004-P | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Current Responsible Party | Abbott Medical Devices | |||||||||
| Original Responsible Party | [Redacted] | |||||||||
| Current Study Sponsor ICMJE | Abbott Medical Devices | |||||||||
| Original Study Sponsor ICMJE | [Redacted] | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Abbott Medical Devices | |||||||||
| Verification Date | June 2022 | |||||||||
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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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