The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayra Guerrero
About this trial
A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve dysfunction (severe stenosis, ≥ moderate to severe regurgitation, or mixed ≥ moderate stenosis and ≥ regurgitation). There are 2 Arms in this study: 1) "Transseptal (TS) Valve-in-MAC" (ViMAC) Arm, and 2) Natural History of Disease Registry (NHDR) for patients treated with medical treatment only (which includes patients who meet inclusion criteria but can't be treated with transeptal ViMAC due to the presence of anatomical exclusion criteria or other exclusion criteria) and have not had other procedures that may impact outcomes (i.e., alcohol septal ablation or radiofrequency ablation). The study also includes a Registry of Permanently Unassigned" for subjects who undergo preemptive septal ablation procedures (alcohol or radiofrequency) in anticipation of continuing onto ViMAC arm, but are not accepted in the ViMAC Study arm or the patient chooses not to undergo ViMAC procedure.
Eligibility criteria
Qualifiers
- 18 years of age or older
-Severe mitral annular calcification with symptomatic mitral valve dysfunction including severe mitral stenosis defined as mitral valve area (MVA) of ≤1.5 cm2, or ≥ moderate to severe mitral regurgitation, or mixed ≥ moderated stenosis and ≥ moderate regurgitation. For this study, the severity of mitral regurgitation will be graded according to the 2017 American Society of Echocardiography Guidelines: None, Trivial, Mild 1(+), Moderate 2(+), Moderate to severe 3(+), and severe 4(+).
- NYHA Functional Class ≥II.
The heart team agrees that valve implantation will likely benefit the patient.
Disqualifiers
- The heart team considers the patient is a surgical candidate.
- Mitral annulus is not severely calcified.
- Myocardial infarction requiring revascularization within 30 days from procedure.
- Clinically significant untreated coronary artery disease requiring revascularization.
Trial design
Treatments tested in this trial
- Transseptal ViMAC
Treatment groups
210 Participants
are divided into 2 treatment groupsSponsors and collaborators
Mayra Guerrero
Lead sponsor
Mayo Clinic
Sponsor institution
Source ClinicalTrials.gov