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Recruiting NCT06600191

Capstan Medical TMVR Study: FIH

No phase Interventional Mitral Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Capstan System transcatheter mitral valve replacement.
Who it may be relevant to
Registry conditions: Mitral Regurgitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, Chile, New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Incidence of procedural success [Time frame: Procedure through 30 days]
Secondary outcome measures (2)
  • Technical Success [Time frame: 30-Days]
  • Freedom from MAE [Time frame: 30-days, 90-days, 6-months, 1-year, then annually to 5-years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

Australia · 1 center
  • Monash Health, Victorian Heart Hospital — Melbourne
Chile · 1 center
  • Pontificia Universidad Católica de Chile — Santiago
New Zealand · 1 center
  • Auckland City Hospital — Auckland

Identifiers

NCT: NCT06600191 · CL_03945

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗