Capstan Medical TMVR Study: FIH

Launched by CAPSTAN MEDICAL · Sep 16, 2024

Keywords

ClinConnect Summary

The Capstan Medical TMVR Study is a clinical trial looking at a new treatment option for adults who have moderate to severe mitral regurgitation, a condition where the heart’s mitral valve does not close properly, causing blood to flow backward. This study is designed for people who cannot undergo traditional heart surgery and aims to evaluate the safety and effectiveness of the Capstan Medical TMVR System. Right now, the trial is actively recruiting participants who are at least 18 years old and experiencing significant heart symptoms despite taking medications.

To qualify for the study, participants should have moderate to severe symptoms related to their mitral regurgitation, and their heart care team must agree that this new treatment is the best option for them. Those interested in joining the trial can expect to undergo various assessments to ensure their eligibility, including heart imaging tests. It’s important to note that certain health conditions, like severe heart valve problems or recent heart attacks, may prevent someone from participating. If you or a loved one meets the criteria and is interested in learning more, please talk to your healthcare provider about the potential benefits and risks involved.

Gender

ALL

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