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NCT03539458 · ClinicalTrials.gov registry record · NA
Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification
A NA study of Cardiovascular Diseases and Mitral Regurgitation, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
- 4
- Study locations
NCT03539458: Completed NA study of Cardiovascular Diseases and Mitral Regurgitation, sponsored by Abbott Medical Devices.
NCT03539458 is a NA study of Cardiovascular Diseases and Mitral Regurgitation that has completed, run by Abbott Medical Devices. The registered enrollment target is 11 participants, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (100% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03539458, a NA study of Cardiovascular Diseases and Mitral Regurgitation, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular calcification (MAC). Subjects satisfying the study inclusion/exclusion criteria will undergo a procedure to implant the Tendyne mitral valve replacement device.
Primary Outcome
Definition of Device Success: All of the following must be present: 1. Absence of procedural mortality or stroke; and 2. Proper placement and positioning of the device, and 3. Freedom from unplanned surgical or interventional procedures related to the device or access procedure; and 4. Continued intended safety and performance of the device, including: i. No evidence of structural or functional failure ii. No specific device-related technical failure issues or complications iii. Reduction o
Conditions Studied
Interventions
- DEVICE Tendyne Mitral Valve System
Study Locations (4)
Georgia
- Emory University Hospital - Atlanta
Kansas
- Cardiovascular Research Institute of Kansas - Wichita
Minnesota
- Abbott Northwestern Hospital - Minneapolis
West Virginia
- West Virginia University - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-10-10 |
| Est. Completion | 2024-06-18 |
| Phase | NA |
What the finished NCT03539458 record still lists
NCT03539458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (100% lower).
The record links to 9 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 1 intervention - of which Tendyne Mitral Valve System is the first listed.
NCT03539458 reports a single indexed study location in Georgia, Kansas, Minnesota.
Frequently Asked Questions
What is clinical trial NCT03539458 about?
NCT03539458 is a clinical study titled "Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification". This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular calcification (MAC). Subjects satisfying the study inclusion/exclusion cr...
What is the current status of trial NCT03539458?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2018-10-10. Estimated completion is 2024-06-18.
What conditions does trial NCT03539458 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Mitral Regurgitation, Heart Valve Diseases, Mitral Valve Disease, Mitral Insufficiency.
What interventions are being tested in trial NCT03539458?
The interventions under investigation include: Tendyne Mitral Valve System (DEVICE).
Who is sponsoring clinical trial NCT03539458?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03539458 being conducted?
This trial has 4 study locations across Georgia, Kansas, Minnesota, West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03539458's enrollment target sits among peer trials
11 294th of 300 higher than 6 of 300 other Cardiovascular Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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