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Clinical trialNCT02830204CompletedInterventional

Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study

SponsorBaylor Research InstituteEnrollment25Mitral Annular Calcification
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • St. Vincent Heart Center

    Indianapolis, Indiana, United States

  • Mhri Maryland

    Baltimore, Maryland, United States

  • Lankenau Institute for Medical Research

    Wynnewood, Pennsylvania, United States

  • Baylor College of Medicine

    Houston, Texas, United States

  • the Heart Hospital Baylor Plano

    Plano, Texas, United States

  • University of Virginia

    Charlottesville, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
4 Nov 2016
Primary completion
3 Jan 2023
Completion
29 Nov 2023
Last update posted
24 Feb 2025
Registered enrollment
25
Registry id
NCT02830204
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.