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NCT06951672 · ClinicalTrials.gov registry record · NA
AMEND TS Early Feasibility Study
A NA study of Symptomatic Functional MR 3 or Greater, sponsored by Valcare Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 11
- Study locations
NCT06951672 is a NA study of Symptomatic Functional MR 3 or Greater that is actively recruiting participants, run by Valcare Medical. The registered enrollment target is 15 participants. The trial reports 11 study locations across 9 states.
The verdict
NCT06951672, a NA study of Symptomatic Functional MR 3 or Greater, is actively recruiting participants, sponsored by Valcare Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 11
- Study locations
Study Summary
Valcare Medical AMEND Trans-Septal System is a mitral valve repair annuloplasty ring implanted in a trans-catheter method intended for correction of mitral regurgitation. It is designed to be used as standalone therapy or in combination with other repair treatments.
Conditions Studied
Interventions
- DEVICE This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation.
Study Locations (11)
New York
- Columbia University Medical Center (CUMC) - New York
- Montefiore Medical Center - The Bronx
Texas
- University of Texas Health Science Center (UTH) - Houston
- Methodist Hospital HCA - San Antonio
Arizona
- Banner University Medical Center - Phoenix - Phoenix
California
- Scripps Health - La Jolla
Georgia
- Piedmont Healthcare - Atlanta
Indiana
- Ascension St. Vincent - Indianapolis
Oregon
- Oregon Health & Science University (OHSU) - Portland
Tennessee
- Saint Thomas Research Institute - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-09-11 |
| Est. Completion | 2027-04 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06951672
The ClinicalTrials.gov registry entry for NCT06951672 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Valcare Medical, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Symptomatic Functional MR 3 or Greater appearing as the primary indexed condition, and to 1 intervention - of which This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation. is the first listed.
NCT06951672 reports 11 study locations spanning 9 distinct geographic areas - top geographies include New York, Texas, Arizona.
Frequently Asked Questions
What is clinical trial NCT06951672 about?
NCT06951672 is a clinical study titled "AMEND TS Early Feasibility Study". Valcare Medical AMEND Trans-Septal System is a mitral valve repair annuloplasty ring implanted in a trans-catheter method intended for correction of mitral regurgitation. It is designed to be used as standalone therapy or in combination with other repair treatments.
What is the current status of trial NCT06951672?
This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2025-09-11. Estimated completion is 2027-04.
What conditions does trial NCT06951672 study?
This clinical trial studies the following conditions: Symptomatic Functional MR 3 or Greater.
What interventions are being tested in trial NCT06951672?
The interventions under investigation include: This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation. (DEVICE).
Who is sponsoring clinical trial NCT06951672?
This trial is sponsored by Valcare Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06951672 being conducted?
This trial has 11 study locations across Arizona, California, Georgia, Indiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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