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NCT02830204 · ClinicalTrials.gov registry record · NA
Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study
A NA study of Mitral Annular Calcification, sponsored by Baylor Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 6
- Study locations
NCT02830204 is a NA study of Mitral Annular Calcification that has completed, run by Baylor Research Institute. The registered enrollment target is 25 participants. The trial reports 6 study locations across 5 states.
The verdict
NCT02830204, a NA study of Mitral Annular Calcification, has completed, sponsored by Baylor Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3 valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis (MS) and/or mitral regurgitation who are at high-risk for mitral valve surgery or deemed inoperable due to the extent of calcification.
Conditions Studied
Interventions
- DEVICE Mitral Valve Replacement (MVR) with Sapien3
Study Locations (6)
Texas
- Baylor College of Medicine - Houston
- The Heart Hospital Baylor Plano - Plano
Indiana
- St. Vincent Heart Center - Indianapolis
Maryland
- MHRI Maryland - Baltimore
Pennsylvania
- Lankenau Institute for Medical Research - Wynnewood
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2016-11-04 |
| Est. Completion | 2023-11-29 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02830204
The ClinicalTrials.gov registry entry for NCT02830204 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor Research Institute, which has 180 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Mitral Annular Calcification appearing as the primary indexed condition, and to 1 intervention - of which Mitral Valve Replacement (MVR) with Sapien3 is the first listed.
NCT02830204 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Texas, Indiana, Maryland.
Frequently Asked Questions
What is clinical trial NCT02830204 about?
NCT02830204 is a clinical study titled "Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study". The purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3 valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis (MS) and/or mitral regurgitation who are at high-risk for mitral valve surgery or deemed inoperable due to the extent...
What is the current status of trial NCT02830204?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2016-11-04. Estimated completion is 2023-11-29.
What conditions does trial NCT02830204 study?
This clinical trial studies the following conditions: Mitral Annular Calcification.
What interventions are being tested in trial NCT02830204?
The interventions under investigation include: Mitral Valve Replacement (MVR) with Sapien3 (DEVICE).
Who is sponsoring clinical trial NCT02830204?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02830204 being conducted?
This trial has 6 study locations across Indiana, Maryland, Pennsylvania, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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