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
This trial does not accept healthy volunteersQualifiers
- 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
Design model
Parallel
Treatments tested in this trial
Transseptal ViMAC
DeviceTransseptal TMVR using balloon-expandable aortic transcatheter valves.
Treatment groups
210 Participants
are divided into 2 treatment groupsGroup A: Transseptal ViMACExperimental treatment 1 intervention
Group B: Registry of untreated patientsNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Primary Safety Endpoint: All Cause Morality and Hospitalization for Heart Failure
A non-hierarchical composite of all-cause mortality and hospitalization for heart failure.
Time frame
1 year.Secondary outcomes
1
Secondary Effectiveness Endpoint
• Stroke at 30 days and 1 year.
Time frame
1 year2
Secondary Effectiveness Endpoint
• Change from baseline in New York Heart Association Class at 1 year.
Time frame
1 year.3
Secondary Effectiveness Endpoint
• Change from baseline in distance walked measure by the 6 Minute Walk Test at 1 year.
Time frame
1 year.4
Secondary Effectiveness Endpoint
• Change from baseline in quality-of-life measure by the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 1 year.
Time frame
1 year.Other outcomes
1
Additional Endpoint: Technical Success
• Technical success at exit from the cath lab. Defined as: * Successful vascular access, delivery and retrieval of the transcatheter valve delivery system. * Deployment of a single valve. * Correct position of transcatheter valve in the mitral annulus. * Adequate performance of the prosthetic heart valve (MVA \> 1.5 cm2) without residual mitral regurgitation grade ≥2 (+). * No need for additional surgery or re-intervention (includes drainage of pericardial effusion). * The patient leaves the cath lab alive.
Time frame
Immediately after the intervention procedure.2
Additional Endpoint: Procedural Success
• Procedural Success at 30 days. Defined as: * Device success at 30 days. * No device/procedure related SAE's including: death, stroke, MI or coronary ischemia requiring PCI or CABG, stage 2 or 3 AKI including dialysis, life threatening bleeding, major vascular or access complications (arterial, venous, or TA - any event requiring additional unplanned surgical or transcatheter intervention), pericardial effusion or tamponade requiring drainage, severe hypotension, heart failure or respiratory failure requiring intravenous pressors or invasive or mechanical treatments such as ultrafiltration or hemodynamic assist devices including intra-aortic balloon pump or left ventricular assist device, or prolonged intubation for ≥48 hrs, or any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention.
Time frame
30 days3
Additional Endpoint: Device Success
Device success is defined as: * Stroke free survival with original valve in place. * No need for additional surgery or re-intervention related to the procedure, access or to the replacement valve. * Proper placement and intended function of the replacement valve, including * No migration, fracture, thrombosis, hemolysis or endocarditis. * No replacement valve stenosis (MV gradient \< 10 mmHg). * Replacement valve regurgitation \< 2 + (including central and paravalvular leak) and without associated hemolysis. * No increase in AI from baseline (more than 1 grade) and LVOT gradient \< 20 mmHg increase from baseline.
Time frame
30 days.4
Additional Efficacy Endpoint - NYHA Class at 30 days.
• Change from baseline in NYHA Class at 30 days.
Time frame
30 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayra Guerrero
Lead sponsor
Mayo Clinic
Sponsor institution
Source ClinicalTrials.gov