Mitral Annular CalcificationMITRAL-IINCT04408430
The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).
A study testing Transseptal ViMAC in people with Mitral Annular Calcification and Mitral Stenosis, run by Mayra Guerrero at 17 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Annular Calcification, Mitral Stenosis, Mitral Regurgitation
- What is being tested?
- Transseptal ViMAC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 8 Mar 2021to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 ≥ 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.
- 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 inclusion to ViMAC arm). NOTE: Patients not interested in mitral intervention or who are being considered for inclusion in the Natural History of Disease Registry are not required to be evaluated in person by a surgeon.)
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- 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.
- Exclusion Criteria for ViMAC subjects (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). Implantation of a permanent pacemaker is not exclusionary.
- 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 < 275 mm2 or > 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 for inclusion in this trial.
- - 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.
Who cannot join
None listed.
Trial locations and contacts
17 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 2 countries
United States16 sites, 13 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Lina Fu, (617) 643-1371, lfu2@mgh.harvard.edu
Ignacio Inglessis, MD
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Sinead Coyle, scoyle3@bwh.harvard.edu
Pinak Shah, MD
- Active, not recruiting
Uchealth Heart & Vascular Clinic Harmony Campus
Fort Collins, Colorado, 80528
- Recruiting
Dignity Health Chandler Regional Medical Center
Gilbert, Arizona, 85297
Jennifer Vermillion, jennifer.vermillion@dignityhealth.org
Natalie Wiley, natalie.wiley@commonspirit.org
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Khaled Alsabaawi, Khaled.Alsabaawi@cshs.org
Raj Makkar, MD
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
Brenda Carroll, Brenda.Carroll@imail.org
Brian Whisenant, MD
- Recruiting
Columbia University Medical Center/NYPH
New York, New York, 10032
Kate Dalton, keb2114@cumc.columbia.edu
Morgan Panitchpakdi, M.S., (831) 430-6742, mwp2127@cumc.columbia.edu
- Active, not recruiting
The Sentara Heart Valve and Structural Disease Center
Norfolk, Virginia, 23507
- Recruiting
Banner - University Medicine Cardiology Clinic
Phoenix, Arizona, 85006
Yi Dai, 312-237-5891, daliseshatz@arizona.edu
Philip Gideon, MD
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Zachary Taylor, taylorza@ohsu.edu
Firars Zahr, MD
- Active, not recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
University Health
San Antonio, Texas, 78229
Rachel Steiner, (210) 743-6453, Rachel.Steiner@uhtx.com
Sean Moore, Sean.Moore2@uhtx.com
- Recruiting
Sutter Health
San Francisco, California, 94109
Milena Ferreira, (415) 600-5707, ferreiml@sutterhealth.org
David Daniels, MD
- Recruiting
Pima Heart & Vascular
Tucson, Arizona, 85712
Adriana Olivares, MD, (520) 324-1560, Adriana.Olivares@tmcaz.com
Thomas E Waggoner, DO
- Recruiting
Oklahoma Heart Institute Utica Office
Tulsa, Oklahoma, 74104
Ashlee Ritter, ashlee.smithritter@oklahomaheart.com
Kamran I Muhammad, MD
- Recruiting
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 200100
Eric Collins, 202-877-6622, erin.c.collins@medstar.net
Lowell Satler, MD
Mexico1 site, 1 recruiting
- Recruiting
Ignacio Chávez National Institute of Cardiology
Mexico City, 14080
Gian Manuel Jimenez Rodriguez, MD, gian.jimenez@cardiologia.org.mx
Ruiz Beltran Arturo Maximiliano, MD, arturo.ruiz@cardiologia.org.mx
About this study
Official title: The Safety and Effectiveness of the Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA (SAPIEN 3/Ultra/RESILIA) Valve in Patients With Symptomatic Severe Calcific Mitral Valve Disease With Severe Mitral Annular Calcification Who Are Not Candidates for Standard Mitral Valve Surgery.
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.
Read the detailed description
STUDY OBJECTIVE
The purpose of this study is to establish the safety and effectiveness of the Edwards SAPIEN 3, SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA (SAPIEN 3/Ultra/RESILIA) valves with Commander delivery system in patients with severe mitral annular calcification and symptomatic mitral valve dysfunction who are not candidates for standard mitral valve surgery.
STUDY DESIGN
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, 2) Natural History of Disease Registry (NHDR). Patients treated with medical treatment only (which will include patients who meet inclusion criteria but can't be treated with transseptal 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, radiofrequency ablation).
Enrollment Enrollment will consist of 110 patients in the treatment arm (transseptal ViMAC) and up to 100 in the medically treated arm).
- Being tested
- Transseptal ViMAC
- Keywords
- Transcatheter Mitral Valve Replacement
- Medical subject headings
- Mitral Valve Stenosis, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transseptal ViMACDevice
Also called ViMAC
Transseptal TMVR using balloon-expandable aortic transcatheter valves.
| Study group | Role | What they receive |
|---|---|---|
| Transseptal ViMAC | Experimental | 110 MAC patients treated with transseptal Valve-in-MAC. Receives: Device: Transseptal ViMAC |
| Registry of untreated patients | No intervention | 100 MAC patients not eligible for transseptal ViMAC, treated with conservative management including medications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint: All Cause Morality and Hospitalization for Heart Failure
A non-hierarchical composite of all-cause mortality and hospitalization for heart failure.
Measured: 1 year.
Secondary outcomes (6)
Secondary Effectiveness Endpoint
- Stroke at 30 days and 1 year.
Measured: 1 year
Secondary Effectiveness Endpoint
- Change from baseline in New York Heart Association Class at 1 year.
Measured: 1 year.
Secondary Effectiveness Endpoint
- Change from baseline in distance walked measure by the 6 Minute Walk Test at 1 year.
Measured: 1 year.
Secondary Effectiveness Endpoint
- Change from baseline in quality-of-life measure by the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 1 year.
Measured: 1 year.
Secondary Effectiveness Endpoint
- Echocardiographic assessment of degree of mitral regurgitation (central and paravalvular) at 1 year.
Measured: 1 year.
Secondary Effectiveness Endpoint
- Significant mitral stenosis defined as mean mitral valve gradient by echo > 10 mmHg at 1 year.
Measured: 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start8 Mar 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mitral Annular CalcificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 210 subjects: 110 in treatment arm and 100 in registry of medical treatment for patients who are not eligible for treatment.
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayra Guerrero
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mayra Guerrero, Mayo Clinic
- Investigators
- Mayra Guerrero, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408430
- Sponsor's protocol ID
- 20-002438
- Acronym
- MITRAL-II
- Status last verified
- Jan 2026
- First submitted
- 19 May 2020
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Russell HM, Guerrero ME, Salinger MH, Manzuk MA, Pursnani AK, Wang D, Nemeh H, Sakhuja R, Melnitchouk S, Pershad A, Fang HK, Said SM, Kauten J, Tang GHL, Aldea G, Feldman TE, Bapat VN, George IM. Open Atrial Transcatheter Mitral Valve Replacement in Patients With Mitral Annular Calcification. J Am Coll Cardiol. 2018 Sep 25;72(13):1437-1448. doi: 10.1016/j.jacc.2018.07.033.
PubMed 30236304Guerrero M, Wang DD, Himbert D, Urena M, Pursnani A, Kaddissi G, Iyer V, Salinger M, Chakravarty T, Greenbaum A, Makkar R, Vahanian A, Feldman T, O'Neill W. 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. Catheter Cardiovasc Interv. 2017 Dec 1;90(7):1220-1226. doi: 10.1002/ccd.26975. Epub 2017 Mar 7.
PubMed 28266162Guerrero M, Wang DD, O'Neill W. Percutaneous alcohol septal ablation to acutely reduce left ventricular outflow tract obstruction induced by transcatheter mitral valve replacement. Catheter Cardiovasc Interv. 2016 Nov 15;88(6):E191-E197. doi: 10.1002/ccd.26649. Epub 2016 Jul 5.
PubMed 27377756Guerrero 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.
PubMed 27094423Guerrero M, Greenbaum A, O'Neill W. First in human percutaneous implantation of a balloon expandable transcatheter heart valve in a severely stenosed native mitral valve. Catheter Cardiovasc Interv. 2014 Jun 1;83(7):E287-91. doi: 10.1002/ccd.25441. Epub 2014 Mar 14.
PubMed 24532349Guerrero 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.
PubMed 29699609
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectiveness of the Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA (SAPIEN 3/Ultra/RESILIA) Valve in Patients With Symptomatic Severe Calcific Mitral Valve Disease With Severe Mitral Annular Calcification Who Are Not Candidates for Standard Mitral Valve Surgery.
- ClinicalTrials.gov ID
- NCT04408430
- Acronym / sponsor ID
- MITRAL-II / 20-002438
- Keywords
- Transcatheter Mitral Valve Replacement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Mayra GuerreroUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
STUDY OBJECTIVE
The purpose of this study is to establish the safety and effectiveness of the Edwards SAPIEN 3, SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA (SAPIEN 3/Ultra/RESILIA) valves with Commander delivery system in patients with severe mitral annular calcification and symptomatic mitral valve dysfunction who are not candidates for standard mitral valve surgery.
STUDY DESIGN
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, 2) Natural History of Disease Registry (NHDR). Patients treated with medical treatment only (which will include patients who meet inclusion criteria but can't be treated with transseptal 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, radiofrequency ablation).
Enrollment Enrollment will consist of 110 patients in the treatment arm (transseptal ViMAC) and up to 100 in the medically treated arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 210 subjects: 110 in treatment arm and 100 in registry of medical treatment for patients who are not eligible for treatment.
| Arm | Type | Receives |
|---|---|---|
| Transseptal ViMAC | Experimental | Device: Transseptal ViMAC110 MAC patients treated with transseptal Valve-in-MAC. |
| Registry of untreated patients | No intervention | –100 MAC patients not eligible for transseptal ViMAC, treated with conservative management including medications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (40 listed)
- - 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.
- 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 inclusion to ViMAC arm). NOTE: Patients not interested in mitral intervention or who are being considered for inclusion in the Natural History of Disease Registry are not required to be evaluated in person by a surgeon.)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transseptal ViMACAlso: ViMACTransseptal TMVR using balloon-expandable aortic transcatheter valves. | Device | Transseptal ViMAC |
Primary outcome
Primary Safety Endpoint: All Cause Morality and Hospitalization for Heart Failure
Time frame: 1 year.
A non-hierarchical composite of all-cause mortality and hospitalization for heart failure.
6 secondary outcomes
Secondary Effectiveness Endpoint
Time frame: 1 year
Secondary Effectiveness Endpoint
Time frame: 1 year.
Secondary Effectiveness Endpoint
Time frame: 1 year.
Secondary Effectiveness Endpoint
Time frame: 1 year.
Secondary Effectiveness Endpoint
Time frame: 1 year.
Secondary Effectiveness Endpoint
Time frame: 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Background: PubMed 30236304Russell HM, Guerrero ME, Salinger MH, Manzuk MA, Pursnani AK, Wang D, Nemeh H, Sakhuja R, Melnitchouk S, Pershad A, Fang HK, Said SM, Kauten J, Tang GHL, Aldea G, Feldman TE, Bapat VN, George IM. Open Atrial Transcatheter Mitral Valve Replacement in Patients With Mitral Annular Calcification. J Am Coll Cardiol. 2018 Sep 25;72(13):1437-1448. doi: 10.1016/j.jacc.2018.07.033.
- Background: PubMed 28266162Guerrero M, Wang DD, Himbert D, Urena M, Pursnani A, Kaddissi G, Iyer V, Salinger M, Chakravarty T, Greenbaum A, Makkar R, Vahanian A, Feldman T, O'Neill W. 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. Catheter Cardiovasc Interv. 2017 Dec 1;90(7):1220-1226. doi: 10.1002/ccd.26975. Epub 2017 Mar 7.
- Background: PubMed 27377756Guerrero M, Wang DD, O'Neill W. Percutaneous alcohol septal ablation to acutely reduce left ventricular outflow tract obstruction induced by transcatheter mitral valve replacement. Catheter Cardiovasc Interv. 2016 Nov 15;88(6):E191-E197. doi: 10.1002/ccd.26649. Epub 2016 Jul 5.
- Background: PubMed 27094423Guerrero 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.
- Background: PubMed 24532349Guerrero M, Greenbaum A, O'Neill W. First in human percutaneous implantation of a balloon expandable transcatheter heart valve in a severely stenosed native mitral valve. Catheter Cardiovasc Interv. 2014 Jun 1;83(7):E287-91. doi: 10.1002/ccd.25441. Epub 2014 Mar 14.
- Results publication: PubMed 29699609Guerrero 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mayra Guerrero, MD principal investigator
Mayo Clinic
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transseptal ViMAC in people with Mitral Annular Calcification and Mitral Stenosis, run by Mayra Guerrero at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 40 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Kaptzan, Ph. D. (507-284-1610, kaptzan.tatiana@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint: All Cause Morality and Hospitalization for Heart Failure (time frame: 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04408430, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.