A Study to Evaluate the Innovalve Transseptal Mitral Valve Replacement System to Treat Patients with Mitral Valve Regurgitation

Overview

About this study

The purpose of this study is to assess the technical and procedural success of the Innovalve TMVR system when used to treat adult patients with symptomatic moderate-severe and severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement and who are anatomically eligible for a transfemoral catheterization with transseptal approach to the left atrium.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years.
  • Moderate-severe or severe mitral regurgitation (MR Grade 3-4+), either DMR (Degenerative Mitral Regurgitation) or FMR (Functional Mitral Regurgitation).
  • Symptomatic mitral regurgitation (NYHA Class II-IV) despite optimal guide line directed medical therapy (GDMT).
  • Deemed to be at elevated risk for conventional mitral valve surgery by the local heart team (including, at minimum, a cardiac surgeon, interventional cardiologist, a specialist in heart failure and an echocardiographer) based on STS PROM risk calculator >6%, or determination by the local heart team of significantly elevated risk of 30-day mortality.
  • Anatomically suitable for transseptal access and Innovalve TMVR implantation as per Case Review Committee (CRC).
  • Willing to sign Informed Consent for participation in the study and return for all required post-procedure follow-up visits.

Exclusion Criteria:

  • Left ventricular ejection fraction (LVEF) < 30%.
  • Evidence of intracardiac mass, thrombus, or vegetation.
  • Severe pulmonary hypertension (systolic PA pressure > 75% of systemic pressure).
  • Prior mitral valve surgery or endovascular procedure, any currently implanted mechanical prosthetic valve, or need for other valve surgery/procedure.
  • Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to enrollment.
  • Prior stroke within 6 months.
  • Need for coronary revascularization at the same time as mitral valve replacement.
  • Active endocarditis, or within the last 6 months.
  • GI bleeding within 6 months.
  • History of bleeding diathesis or coagulopathy or patient will refuse blood transfusion.
  • Hemodynamic instability, requiring mechanical hemodynamic support.
  • Platelet count of < 75,000 cells/mm^3 .
  • Severe kidney dysfunction (eGFR < 30mL/min). 
  • Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics).
  • Contraindication to transesophageal echocardiography (TEE).
  • Known hypersensitivity or contraindication to study or procedure medications/contrast which cannot be adequately managed medically.
  • Pregnancy.
  • Any anatomy or prior intervention that would preclude a transseptal approach (including, but not limited to, prior IVC filter placement, prior ASD, or prior FPO closure device implantation).
  • Severe Tricuspid Regurgitation or severe right ventricular dysfunction.
  • Native mitral valve size NOT compatible with the Innovalve TMVR System:
    • Mitral valve annulus mean diameters range (CC\AP) < 2.5cm or > 5cm by 4D-CT/TEE);
    • If the subject presents with degenerative MR and any of the following:
      • bi-leaflet flail;
      • moderate or severe MAC.
  • Any other anatomical representation which is found inadequate with Innovalve TMVR System, as deemed by Case Review Committee (CRC) .
  • Over 30% of chordae appear torn.
  • Inadequate venous access for 32Fr system.
  • Expected risk of LVOT obstruction following preoperative imaging studies.
  • Inadequate imaging.
  • Inordinate surgical risk that would preclude rescue surgery.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Charanjit Rihal, M.D.

Open for enrollment

Contact information:

Carol Kerian Masters R.N.

(507) 422-2094

Kerian-Masters.Carol@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20520959

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