Clinical trial NCT06600191: Capstan Medical TMVR Study: FIH
Official title: Capstan Medical TMVR Study: First-in-Human Evaluation of the Capstan TMVR System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Keywords: TMVR
mitral regurgitation
Lead sponsor: Capstan Medical
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


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

Primary outcomes:
measure: Incidence of procedural success
timeFrame: Procedure through 30 days
Secondary outcomes:
measure: Technical Success
timeFrame: 30-Days
measure: Freedom from MAE
timeFrame: 30-days, 90-days, 6-months, 1-year, then annually to 5-years
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Monash Health, Victorian Heart Hospital
city: Santiago
country: Chile
facility: Pontificia Universidad Católica de Chile
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
References: