First use of Capstan Medical's device for mitral valve replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and feasibility of the Capstan Medical TMVR System in adults with moderate to severe mitral regurgitation who are not candidates for surgical intervention. It is a prospective, multi-center, non-randomized study that aims to gather data on the device's performance in a real-world clinical setting. Participants will be monitored for outcomes related to the intervention, including any adverse events. The study is designed to provide insights into the effectiveness of this novel approach to treating mitral valve issues.

Why it matters

Who can join: the full rules

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

Where it's running

• Pontificia Universidad Católica de Chile
  Santiago, Chile Recruiting
• Auckland City Hospital
  Auckland, New Zealand Recruiting
• Monash Health, Victorian Heart Hospital
  Melbourne, Australia Not yet recruiting
• Instituto do Coração de São Paulo Incor
  São Paulo, Brazil Not yet recruiting

Study contacts

• Study coordinator: Anamiriam Arroyo
• Email: anamiriam.arroyo@capstanmedical.com
• Phone: 4087108955

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Posterior Mitral Leaflet Replacement to Reduce Mitral Regurgitation

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• Replacing the native mitral valve with the ReValve System

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• Mitral valve replacement with the SATURN TMVR system for severe mitral regurgitation

  This study tests whether the SATURN TS transcatheter mitral valve replacement can be safely implanted and work well in adults with severe mitral regurgitation who are high-risk for open-heart surgery.

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• Outcomes after new edge-to-edge mitral valve repair

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• Surgical implantation of a polymer prosthetic mitral or aortic valve

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• GeminiOne transcatheter edge-to-edge repair for severe symptomatic mitral regurgitation

  This trial will try the GeminiOne TEER system to treat adults with severe, symptomatic mitral regurgitation who are high surgical risk or have not improved with medical therapy.

  Recruiting Sierra Valve LLC · Thousand Oaks, California · NCT07086534

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.