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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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
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