AMEND TS Early Feasibility Study
Public ClinicalTrials.gov record NCT06951672. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The AMEND TS Early Feasibility Study is a Prospective, Single-arm, Multi-center Study to Evaluate the Safety and Function of the AMEND(TM) Trans-Septal System for MR Reduction; Up to 15 Subjects Will be Enrolled in up to 7 Investigational Centers in the U.S. and Canada With a 30d Safety Endpoint
Study identification
- NCT ID
- NCT06951672
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Lead sponsor
- Valcare Medical Ltd.
- Industry
- Enrollment
- 15 participants
Conditions and interventions
Conditions
Interventions
- This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation. Device
Device
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 10, 2025
- Primary completion
- Sep 30, 2026
- Completion
- Mar 31, 2027
- Last update posted
- Jan 6, 2026
2025 – 2027
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner University Medical Center - Phoenix | Phoenix | Arizona | 85006 | Recruiting |
| Scripps Health | La Jolla | California | 92037 | Not yet recruiting |
| Piedmont Healthcare | Atlanta | Georgia | 30309 | Not yet recruiting |
| Ascension St. Vincent | Indianapolis | Indiana | 46260 | Recruiting |
| Columbia University Medical Center (CUMC) | New York | New York | 10032 | Recruiting |
| Montefiore Medical Center | The Bronx | New York | 10467 | Not yet recruiting |
| Oregon Health & Science University (OHSU) | Portland | Oregon | 97239 | Recruiting |
| Saint Thomas Research Institute | Nashville | Tennessee | 37205 | Not yet recruiting |
| University of Texas Health Science Center (UTH) | Houston | Texas | 77030 | Recruiting |
| Methodist Hospital HCA | San Antonio | Texas | 78229 | Recruiting |
| Intermountain Health | Murray | Utah | 84107 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06951672, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 6, 2026 · Synced May 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06951672 live on ClinicalTrials.gov.