Percutaneous repair of the tricuspid valve using the Mistral device

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 effectiveness of the Mistral device for percutaneous treatment of patients with symptomatic moderate or greater tricuspid regurgitation who are at high risk for traditional surgery. Participants will undergo the Mistral procedure, and the study will assess major device-related adverse events and improvements in tricuspid regurgitation severity through echocardiography. The study aims to provide a less invasive option for patients who cannot undergo standard surgical repair.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements
* Subject is ≥ 18 years of age or legal age in host country
* Minimum of moderate functional or degenerative tricuspid regurgitation:

  * Subjects with moderate TR: Only NYHA (New York Heart Association) Class III or IV maybe considered for inclusion.
  * Subjects with severe or greater TR: NYHA (New York Heart Association) Class II, III, or IV may be considered for inclusion
* Subject has left ventricular ejection fraction (LVEF) \>20 %
* The subject is at high risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon and an interventional cardiologist at the site (center heart team).
* Femoral or Jugular access of the Steerable Catheter with MDS (Mistral Delivery System) is determined to be feasible.
* Subject must agree not to start participating in any other clinical trial for a period of 6 months following the index procedure.
* As determined by the center heart team, the Mistral is the suitable treatment option.

Exclusion Criteria:

* Tricuspid Stenosis \>mild
* Tricuspid Sub valvular calcification or calcification of the chordae.
* Subjects with Mitral valve severe stenosis and/or severe regurgitation.
* Previous tricuspid valve repair or replacement that would interfere with placement of Mistral
* Subjects with severe, uncontrolled hypertension.
* Subjects, which need to undergo an emergency surgery.
* Subject is currently participating in another clinical trial that has not yet completed its primary endpoints.
* Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 30 days.
* Subject has a history of a myocardial infarction (MI) in the past 30 days.
* Subject has had a percutaneous coronary intervention (PCI), within the last 30 days before procedure.
* Subject with active endocarditis.
* Subject has echocardiographic evidence of intra-cardiac mass, thrombus, vegetation or soft-mobile deposits.
* Subject has hemodynamic instability requiring inotropic or mechanical support.
* Subject has a known hypersensitivity or contraindication to anticoagulant and antiplatelet medication.
* Subject is on chronic dialysis.
* Bleeding disorders or hypercoagulable state.
* In the judgment of the Investigator, co-morbid condition(s) that could limit the subject's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study.
* Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding.
* Subject has a known allergy to Nitinol alloys, 316L\\304 stainless steel.
* Pregnant or lactating women.
* Patients being dependent upon the sponsor or upon the investigator or upon the investigational site.
* According to investigator on site the patient is suffering from a severe end stage disease (e.g. malignancy, severe pulmonary disease, liver disease, renal failure).
* Contraindication for TEE (transesophageal echocardiography) including trans-gastric views.
* Life expectancy of less than 1 year

Where it's running

• Wolfson Medical Center
  H̱olon, Israel Recruiting

Study contacts

• Principal investigator: Ronen Rubinshtein — Wolfson
• Study coordinator: Dana Yaron
• Email: dana@mitralix.com
• Phone: +972542330022

Similar studies

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

• TruGamma tricuspid valve replacement for high-risk patients

  This trial tests the TruGamma tricuspid valve replacement system in high-risk patients with severe tricuspid regurgitation to see if it is safe and helps symptoms when added to standard medical care.

  Recruiting Jiangsu Trulive Medical Co., Ltd · Beijing, Beijing Municipality · NCT07691307

• Transcatheter Tricuspid Valve Replacement for Severe Tricuspid Regurgitation

  This trial tests the Laplace TTVR System to see if it safely and effectively treats adults with severe tricuspid regurgitation.

  Recruiting at 2 sites Laplace Interventional, Inc · Tulsa, Oklahoma and 1 other locations · NCT07687485

• Vyne TriNova Transcatheter Tricuspid Valve Replacement study for severe tricuspid regurgitation

  This trial tests the VDyne TriNova system in adults with symptomatic severe tricuspid regurgitation to see if it is safe and helps heart symptoms compared with an alternative device.

  Recruiting at 12 sites VDyne, Inc. · Phoenix, Arizona and 11 other locations · NCT07516444

• Lead-related tricuspid valve leakage after first-time pacemaker or ICD implantation

  This project will see if a new transvenous pacemaker or ICD lead causes new or worse tricuspid valve regurgitation in people getting their first device.

  Recruiting Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW · Bad Oeynhausen, North Rhine-Westphalia · NCT07342036

• Tracking progression and consequences of heart valve disease

  This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.

  Recruiting at 15 sites Second Affiliated Hospital, Zhejiang University, School of Medicine · Fuzhou, Fujian and 14 other locations · NCT07267117

• Assessment of the inQB8 Tricuspid Valve Replacement System

  This study is testing a new valve replacement system to see if it can safely help people with severe tricuspid valve problems feel better.

  Recruiting at 8 sites inQB8 Medical Technologies, LLC · Los Angeles, California and 7 other locations · NCT06611579

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.