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Transcatheter Valve

Mitral Valve Replacement with Sapien3 for Mitral Annular Calcification (SITRAL Trial)

N/A
Waitlist Available
Led By Robert Smith, MD
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

SITRAL Trial Summary

This trial will test the safety of a new valve for people with MAC who are at high risk for mitral valve surgery.

Eligible Conditions
  • Mitral Annular Calcification

SITRAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Procedural success
Technical success
Secondary outcome measures
Device Success
Device success
Subject success

SITRAL Trial Design

1Treatment groups
Experimental Treatment
Group I: Mitral Valve Replacement with Sapien3Experimental Treatment1 Intervention
subjects with surgical MVR with Sapien3
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mitral Valve Replacement with Sapien3
2016
N/A
~30

Find a Location

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor
198 Previous Clinical Trials
202,727 Total Patients Enrolled
Edwards LifesciencesIndustry Sponsor
179 Previous Clinical Trials
61,020 Total Patients Enrolled
Robert Smith, MDPrincipal InvestigatorBaylor Research Institute
1 Previous Clinical Trials
1,247 Total Patients Enrolled

Frequently Asked Questions

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~3 spots leftby Mar 2025