Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study of Mitral Annular Calcification, sponsored by Baylor Research Institute.
NCT02830204 is a NA study of Mitral Annular Calcification that has completed, run by Baylor Research Institute. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Procedural Success is defined as: 1. Device success, and 2. No device or procedure related serious adverse events (SAEs) (Life threatening bleed; major vascular or cardiac structural complications requiring unplanned reintervention or surgery; stage 2 or 3 acute kidney injury (AKI) (includes new dialysis); myocardial infarction (MI) or need for percutaneous coronary intervention (PCI)/coronary artery bypass graft (CABG); severe heart failure (HF) or hypotension requiring intravenous (IV) inotro
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 |
What the finished NCT02830204 record still lists
NCT02830204 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
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 lists 6 locations in 5 states (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.
Learn More About Clinical Trials
Similar trials for Mitral Annular Calcification
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02830204's enrollment target sits among peer trials
25 1712th of 2000 higher than 265 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01166854 · 25 participants
Characterization of Familial Myopathy and Paget Disease of Bone
- NCT01913106 · 25 participants · Phase 1
HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer
- NCT02138669 · 25 participants · NA
Intacs Prescription Inserts for Keratoconus Patients
- NCT02174549 · 25 participants · Phase 1
Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI