NCT06600191

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
54mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
3 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Feb 2025Dec 2030

First Submitted

Initial submission to the registry

September 13, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

February 24, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Expected
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

9 months

First QC Date

September 13, 2024

Last Update Submit

April 2, 2025

Conditions

Mitral Regurgitation

Keywords

TMVRmitral regurgitation

Outcome Measures

Primary Outcomes (1)

  • Incidence of procedural success

    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 Outcomes (2)

  • Technical Success

    30-Days

  • Freedom from MAE

    30-days, 90-days, 6-months, 1-year, then annually to 5-years

Study Arms (1)

Implant

EXPERIMENTAL

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

Interventions

Capstan System transcatheter mitral valve replacementDEVICE

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.

Implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Monash Health, Victorian Heart Hospital

Melbourne, Australia

NOT YET RECRUITING

Pontificia Universidad Católica de Chile

Santiago, Chile

RECRUITING

Auckland City Hospital

Auckland, 1023, New Zealand

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

David Ligon, MSE

CONTACT

831-295-5461david.ligon@occam-labs.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2024

First Posted

September 19, 2024

Study Start

February 24, 2025

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2030

Last Updated

April 4, 2025

Record last verified: 2025-04

Locations

AU(1)CL(1)NZ(1)