Capstan Medical TMVR Study: FIH

August 27, 2026 updated by: Capstan Medical

Capstan Medical TMVR Study: First-in-Human Evaluation of the Capstan TMVR System

This study is a prospective, multi-center, non-randomized first in human study to evaluate the safety and feasibility of the Capstan Medical TMVR System for intervention in adults with moderate-severe or greater mitral regurgitation who are not surgical candidates.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Melbourne, Australia
        • Not yet recruiting
        • Monash Health, Victorian Heart Hospital
        • Contact:
  • Brazil
      • São Paulo, Brazil
        • Not yet recruiting
        • Instituto do Coração de São Paulo Incor
        • Contact:
  • Chile
      • Santiago, Chile
        • Recruiting
        • Pontificia Universidad Católica de Chile
        • Contact:
          • Gonzalo Javier Martinez Rodriguez
          • Phone Number: +56 2 23543633
          • Email: gfloresp@uc.cl
  • New Zealand
      • Auckland, New Zealand, 1023
        • Recruiting
        • Auckland City Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years at the time of consent.
  • Moderate-severe (3+) or severe (4+) mitral regurgitation
  • NYHA II or greater symptoms despite optimal medical treatment.
  • The local multi-disciplinary heart team agrees that TMVR is the preferred treatment over surgical intervention or other available treatment options (such as TEER).
  • Ability and willingness to provide written informed consent prior to any study related procedure(s).

Exclusion Criteria:

  • LVEF less than 20%
  • Anatomic features (e.g., annular dimensions, neo-LVOT area, transfemoral and transseptal access, excessive MAC) unsuitable for the Capstan System
  • Severe aortic valve stenosis or regurgitation
  • Severe mitral stenosis
  • Severe right ventricular dysfunction or severe tricuspid valve disease
  • Evidence of intracardiac thrombus, vegetation, or mass
  • Prior mitral valve intervention that would interfere with the appropriate placement of the Capstan Valve
  • Any percutaneous coronary, carotid, or other endovascular intervention within 30 days prior to procedure
  • Myocardial infarction within 30 days prior to procedure
  • Cardiac resynchronization therapy (CRT) device implanted within 30 days of procedure
  • Active endocarditis, other ongoing infection requiring antibiotic therapy
  • Stroke or transient ischemic attack (TIA) within 30 days of procedure
  • Active peptic ulcer or active gastrointestinal bleeding
  • Severe pulmonary arterial hypertension with fixed PASP greater than 85mmHg
  • End-stage renal failure on dialysis
  • Life expectancy less than 1 year
  • Subject is on the waiting list for a heart transplant or has had a prior heart transplant
  • Pregnant (Participants of childbearing age are required to have a negative pregnancy test).
  • Known allergy to antiplatelet therapy, heparin, or to device materials
  • Inability to tolerate anticoagulation or antiplatelet therapies
  • Absence of appropriate venous access
  • Unable to have transesophageal echocardiography
  • Unwillingness to complete the required follow-up visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implant

Participants who pass all screening criteria will undergo a percutaneous procedure for the implantation of a permanent mitral valve replacement device.

Participants will be followed for 5 years to evaluate safety and feasibility of Capstan Medical TMVR System for mitral valve replacement in humans with predominantly regurgitant mitral valves who are symptomatic and who are not good surgical candidates.
Device: Capstan System transcatheter mitral valve replacement
This is a first human use trial exploring a novel transcatheter mitral valve replacement implant and electro-mechanical delivery system. The device offers a minimally invasive repair for patients who have at symptomatic regurgitation who are otherwise ineligable for surgical intervention, or who have no other prospects for treatment and in whom medical therapy has already been optimised.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of procedural success
Time Frame: Procedure through 30 days
Number of participants with successful valve deployment and freedom from death or re-hospitalization for heart failure at 30 days.
Procedure through 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success
Time Frame: 30-Days
Technical success is defined as successful Capstan Valve deployment with none/trace or mild mitral regurgitation at 30 days post- procedure.
30-Days
Freedom from MAE
Time Frame: 30-days, 90-days, 6-months, 1-year, then annually to 5-years

Successful Capstan Valve Deployment with freedom from device- or procedure-related Major Adverse Events (MAE).

MAE is a composite of the following device or procedure related outcomes:

  • All-cause mortality
  • Emergency cardiac or vascular surgery, or re-intervention
  • Myocardial Infarction
  • Stroke
  • Life-threatening bleeding
30-days, 90-days, 6-months, 1-year, then annually to 5-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capstan Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

September 13, 2024

First Submitted That Met QC Criteria

September 16, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL_03945

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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