Study Summary
This trial is testing a new surgical technique, Transseptal Valve-in-MAC, for patients with severe mitral annular calcification and symptomatic mitral valve disease who are at high surgical risk. The control arm will receive medical treatment only.
Eligible Conditions
- Mitral Valve Stenosis
- Mitral Annular Calcification
- Mitral Valve Regurgitation
- Mitral Valve Disease
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 1 year.
1 year.
Additional Efficacy Endpoint - Days Alive Out of the Hospital
Additional Safety Endpoint - Hospitalizations at 1 year
Primary Safety Endpoint: All Cause Morality and Hospitalization for Heart Failure
Secondary Effectiveness Endpoint
30 days
Additional Efficacy Endpoint - MR severity at 30 days
Additional Endpoint: Procedural Success
Year 1
Additional Efficacy Endpoint - Mitral Valve Reintervention
Additional Safety Endpoint - Acute Kidney Injury
Additional Safety Endpoint - Blood Transfusion
Additional Safety Endpoint - Endocarditis
Additional Safety Endpoint - Hemolysis
Additional Safety Endpoint - New Aortic Valve Insufficiency
Additional Safety Endpoint - New LVOT Gradient
Additional Safety Endpoint - New Pacemaker Requirement
Additional Safety Endpoint - Stroke at 30 days and 1 year.
30 days.
Additional Efficacy Endpoint - Distance walked in 6 MWT at 30 days
Additional Efficacy Endpoint - KCCQ at 30 days
Additional Efficacy Endpoint - NYHA Class at 30 days.
Additional Endpoint: Device Success
Additional Safety Endpoint - Need for ASD Closure
Immediately after the intervention procedure.
Additional Endpoint: Technical Success
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Registry of untreated patients
1 of 2
Transseptal ViMAC
1 of 2
Active Control
Experimental Treatment
210 Total Participants · 2 Treatment Groups
Primary Treatment: Transseptal ViMAC · No Placebo Group · Phase 2 & 3
Transseptal ViMAC
Device
Experimental Group · 1 Intervention: Transseptal ViMAC · Intervention Types: DeviceRegistry of untreated patientsNoIntervention Group · 1 Intervention: Registry of untreated patients · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year.
Who is running the clinical trial?
Mayra GuerreroLead Sponsor
1 Previous Clinical Trials
91 Total Patients Enrolled
Mayra Guerrero, MDPrincipal Investigator - Mayo Clinic
Mayo Clinic Hospital-Rochester Saint Marys Campus
University Auto De Baja California (Medical School)
Wm Beaumont Hospital (Residency)
4 Previous Clinical Trials
690 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The medical team agrees that the patient will likely benefit from valve implantation.
References
- Guerrero, Mayra, Danny Dvir, Dominique Himbert, Marina Urena, Mackram Eleid, Dee Dee Wang, Adam Greenbaum, et al.. 2016. “Transcatheter Mitral Valve Replacement in Native Mitral Valve Disease with Severe Mitral Annular Calcification”. JACC: Cardiovascular Interventions. Elsevier BV. doi:10.1016/j.jcin.2016.04.022.
- Guerrero, Mayra, Adam Greenbaum, and William O'Neill. 2014. “First in Human Percutaneous Implantation of a Balloon Expandable Transcatheter Heart Valve in a Severely Stenosed Native Mitral Valve”. Catheterization and Cardiovascular Interventions. Wiley. doi:10.1002/ccd.25441.
- Russell, Hyde M., Mayra E. Guerrero, Michael H. Salinger, Melissa A. Manzuk, Amit K. Pursnani, Dee Wang, Hassan Nemeh, et al.. 2018. “Open Atrial Transcatheter Mitral Valve Replacement in Patients with Mitral Annular Calcification”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2018.07.033.
- Guerrero, Mayra, Marina Urena, Dominique Himbert, Dee Dee Wang, Mackram Eleid, Susheel Kodali, Isaac George, et al.. 2018. “1-year Outcomes of Transcatheter Mitral Valve Replacement in Patients with Severe Mitral Annular Calcification”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2018.02.054.
- Guerrero, Mayra, Dee Dee Wang, Dominique Himbert, Marina Urena, Amit Pursnani, Georges Kaddissi, Vijay Iyer, et al.. 2017. “Short-term Results of Alcohol Septal Ablation as a Bail-out Strategy to Treat Severe Left Ventricular Outflow Tract Obstruction After Transcatheter Mitral Valve Replacement in Patients with Severe Mitral Annular Calcification”. Catheterization and Cardiovascular Interventions. Wiley. doi:10.1002/ccd.26975.
- Guerrero, Mayra, Dee Dee Wang, and William O'Neill. 2016. “Percutaneous Alcohol Septal Ablation to Acutely Reduce Left Ventricular Outflow Tract Obstruction Induced by Transcatheter Mitral Valve Replacement”. Catheterization and Cardiovascular Interventions. Wiley. doi:10.1002/ccd.26649.
- Guerrero M, Urena M, Himbert D, Wang DD, Eleid M, Kodali S, George I, Chakravarty T, Mathur M, Holzhey D, Pershad A, Fang HK, O'Hair D, Jones N, Mahadevan VS, Dumonteil N, Rodes-Cabau J, Piazza N, Ferrari E, Ciaburri D, Nejjari M, DeLago A, Sorajja P, Zahr F, Rajagopal V, Whisenant B, Shah PB, Sinning JM, Witkowski A, Eltchaninoff H, Dvir D, Martin B, Attizzani GF, Gaia D, Nunes NSV, Fassa AA, Kerendi F, Pavlides G, Iyer V, Kaddissi G, Witzke C, Wudel J, Mishkel G, Raybuck B, Wang C, Waksman R, Palacios I, Cribier A, Webb J, Bapat V, Reisman M, Makkar R, Leon M, Rihal C, Vahanian A, O'Neill W, Feldman T. 1-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Mitral Annular Calcification. J Am Coll Cardiol. 2018 May 1;71(17):1841-1853. doi: 10.1016/j.jacc.2018.02.054.
- Guerrero M, Urena M, Pursnani A, Wang DD, Vahanian A, O'Neill W, Feldman T, Himbert D. Balloon expandable transcatheter heart valves for native mitral valve disease with severe mitral annular calcification. J Cardiovasc Surg (Torino). 2016 Jun;57(3):401-9.
- Mayra Guerrero 2021. "The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04408430.
Frequently Asked Questions
Are there any patients that fit the criteria for this research study currently being accepted?
"The listing on clinicaltrials.gov confirms that this research is actively recruiting patients. The 210 participants will be drawn from 22 different locations; the study was first posted on March 8th, 2021." - Anonymous Online Contributor
Unverified Answer
Where can patients receive this type of treatment?
"Beth Israel Deaconess Medical Center in Boston, Columbia University Medical Center in Detroit, and Brigham and Women's Hospital in Tulsa are all running this clinical trial, among other hospitals in 22 additional locations." - Anonymous Online Contributor
Unverified Answer
How many people are being asked to take part in this research project?
"In order to run this study as planned, the research team needs to enroll 210 individuals that fit the pre-specified inclusion criteria. Beth Israel Deaconess Medical Center in Boston, Massachusetts and Columbia University Medical Center in Detroit, Michigan are two of the many locations where potential participants can reside." - Anonymous Online Contributor
Unverified Answer