Capstan Medical TMVR Study: FIH

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: Mitral Regurgitation
• Intervention / Treatment: Device: Capstan System transcatheter mitral valve replacement

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Ligon, MSE; Phone Number: 831-295-5461; Email: david.ligon@occam-labs.com

Study Locations

• Australia
  • Melbourne, Australia
    • Not yet recruiting
    • Monash Health, Victorian Heart Hospital
    • Contact: Robert Gooley; Phone Number: +61 (03) 7511 1111; Email: research@MonashHealth.org
• Chile
  • Santiago, Chile
    • Recruiting
    • Pontificia Universidad Catolica 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: Mark Webster, MD; Phone Number: +64 21 241 2758; Email: charissa@adhb.govt.nz

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	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	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

• Sponsor: Capstan Medical

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2030

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): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: mitral regurgitation; TMVR
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• 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