BridgeMD
New treatment option for Mitral Annular Calcification
Official title The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).
ClinicalTrials.gov ID: NCT04408430
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All Candidates must meet the following criteria:
- \- 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...
- \- NYHA Functional Class ≥II.
- The heart team agrees that valve implantation will likely benefit the patient.
You likely can't join if
- for ViMAC people (does not apply to the Natural History of Disease Registry):
- \- 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.
- Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of...
See the full eligibility criteria
Who can join
- All Candidates must meet the following criteria:
- \- 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 ≥...
- \- NYHA Functional Class ≥II.
- The heart team agrees that valve implantation will likely benefit the patient.
- High or prohibitive risk for standard mitral valve surgery as determined by the heart team (at least one site cardiac surgeon must personally examine the subject to determine operative risk in patients presented for...
- The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years.
What rules you out
- for ViMAC people (does not apply to the Natural History of Disease Registry):
- \- 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.
- Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease)...
- Any patient with a balloon valvuloplasty (BMV) within 30 days of the procedure (unless BMV is a bridge to ViMAC procedure after a qualifying Echo).
- Severe symptomatic tricuspid regurgitation (hepatic dysfunction, ascites, edema not controlled with diuretics) requiring surgery.
- Leukopenia (WBC \< 3000 cell/mL), acute anemia (Hgb \< 9 g/dL), Thrombocytopenia (Platelets \< 50,000 cell/mL), history of coagulopathy or hypercoagulable state.
- Hypertrophic obstructive cardiomyopathy (HOCM) with mean LVOT gradient of ≥20 mm Hg at rest or ≥50 mmHg with Valsalva.
- Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of screening evaluation.
- Need for emergency surgery for any reason.
- Severe left ventricular dysfunction with LVEF \< 20%.
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- Active upper GI bleeding within 90 days prior to procedure.
- A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
- Cardiac anatomy that would preclude appropriate delivery and deployment of an Edwards SAPIEN 3/Ultra/RESILIA valve in MAC via transseptal access, including but not limited to:
- Native neo mitral annulus size \ 810 mm2 as measured by CT scan.
- Significant risk of LVOT obstruction or valve embolization as assessed by CT core lab
- Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 90 days of the procedure.
- Estimated life expectancy \<12 months due to non-cardiac conditions.
- Expectation that patient will not improve despite treatment of mitral valve dysfunction.
- Active bacterial endocarditis within 180 days of procedure.
- \- Severe right ventricular dysfunction as assessed by Echo core lab
- \- Active infection requiring antibiotic therapy (subject may be a candidate after 2 weeks of antibiotic discontinuation.
- \- Female who is pregnant or lactating.
- \- Participating in another investigational device study.
- \- Aortic valve disease requiring intervention. If aortic valve intervention is required, the AVR procedure should be performed first and if the patient remains symptomatic after AVR, may be presented for consideration...
- \- Severe fixed pulmonary hypertension (PASP ≥70 mmHg and more than 2/3 of the systemic systolic blood pressure).
- \- Severe chronic obstructive pulmonary disease requiring continuous home oxygen.
- \- The patient refuses mitral valve intervention
- \- Recent symptomatic COVID-19 infection with residual symptoms that may affect the outcomes of this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Fort Collins, Colorado, United States
- Washington D.C., District of Columbia, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Tulsa, Oklahoma, United States
- Portland, Oregon, United States
- San Antonio, Texas, United States
- Murray, Utah, United States
- Norfolk, Virginia, United States
- Mexico City, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Los Angeles, California, United States; San Francisco, California, United States; Fort Collins, Colorado, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.