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

NCT02830204 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-02-24

Study results available
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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

  • Mitral Annular Calcification

Interventions

DEVICE

Mitral Valve Replacement (MVR) with Sapien3

subjects with surgical MVR with Sapien3

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • Baylor Research Institute

    lead OTHER

Principal Investigators

  • Robert Smith, MD · Baylor Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-04
Primary Completion
2023-01-03
Completion
2023-11-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02830204 on ClinicalTrials.gov