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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
19/09/2024

Titles & IDs
Public title
Capstan Medical TMVR Study: FIH
Scientific title
Capstan Medical TMVR Study: First-in-Human Evaluation of the Capstan TMVR System
Secondary ID [1] 0 0
CL_03945
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mitral Regurgitation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of procedural success
Timepoint [1] 0 0
Procedure through 30 days
Secondary outcome [1] 0 0
Technical Success
Timepoint [1] 0 0
30-Days
Secondary outcome [2] 0 0
Freedom from MAE
Timepoint [2] 0 0
30-days, 90-days, 6-months, 1-year, then annually to 5-years

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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2030
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Aukland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Capstan Medical
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06600191
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David Ligon, MSE
Address 0 0
Country 0 0
Phone 0 0
831-295-5461
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06600191