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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06600191
Registration number
NCT06600191
Ethics application status
Date submitted
13/09/2024
Date registered
19/09/2024
Date last updated
4/04/2025
Titles & IDs
Public title
Capstan Medical TMVR Study: FIH
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Scientific title
Capstan Medical TMVR Study: First-in-Human Evaluation of the Capstan TMVR System
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Secondary ID [1]
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CL_03945
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mitral Regurgitation
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Capstan System transcatheter mitral valve replacement
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.
Treatment: Devices: 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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of procedural success
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Assessment method [1]
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Number of participants with successful valve deployment and freedom from death or re-hospitalization for heart failure at 30 days.
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Timepoint [1]
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Procedure through 30 days
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Secondary outcome [1]
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Technical Success
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Assessment method [1]
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Technical success is defined as successful Capstan Valve deployment with none/trace or mild mitral regurgitation at 30 days post- procedure.
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Timepoint [1]
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30-Days
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Secondary outcome [2]
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Freedom from MAE
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Assessment method [2]
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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
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Timepoint [2]
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30-days, 90-days, 6-months, 1-year, then annually to 5-years
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Eligibility
Key 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).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Other
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/02/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2030
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Monash Health, Victorian Heart Hospital - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Chile
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State/province [1]
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Santiago
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Country [2]
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New Zealand
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State/province [2]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Capstan Medical
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06600191
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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David Ligon, MSE
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Address
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Country
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Phone
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831-295-5461
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06600191
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