Last updated 3 months ago

Capstan Medical TMVR Study: FIH

10 patients around the world

Available in Chile

Capstan Medical

1Research sites

10Patients around the world

This study is for people with

Cardiovascular Disease

Mitral Regurgitation

From 18 Years

All Gender

: 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.
Ability and willingness to provide written informed consent prior to any study related procedure(s).

: LVEF less than 20%.
Anatomic features 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.
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.

Hospital Clínico Pontificia Universidad Católica de Chile - Santiago, Región Metropolitana

Recruiting

Portugal 61, Santiago

SponsorCapstan Medical

Study typeInterventional

Conditions

Mitral Regurgitation

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06600191