Mitral Implantation of TRAnscatheter vaLves

NCT02370511 | Completed Results DMC FDA Device

• 1 other identifier: 18-006601
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of this trial is to establish the safety and feasibility of the Edwards SAPIEN XT™and SAPIEN 3™ device and delivery systems in patients with severe symptomatic calcific mitral valve disease with severe mitral annular calcification who are not candidates for standard mitral valve surgery.

Conditions

Mitral Valve Disease

Outcome Measures

Primary Outcomes (3)

• Technical Success at Exit From the Cath Lab.

  Number of subject to achieve technical success (at exit from cath lab) is defined as: * Successful vascular delivery and retrieval of transcatheter valve delivery system * Deployment of single valve * Correct position of transcatheter valve * Adequate performance of prosthesis (MVA \> 1.5 cm2) without residual MR grade ≥2 (+) * No need for additional surgery or re-intervention * Patient leaves cath lab alive

  30 days

• Absence of MR Grade 2 (+) or Greater

  Number of subjects to have absence of MR grade 2 (+) or greater assessed with echocardiography. MR severity grading system ranging from Grade 1=mild; Grade 4=severe.

  30 days and 1 year

• Mitral Valve Gradient (MVG)

  MVG assessed by echocardiography measured in mmHg

  30 days and 1 year

Secondary Outcomes (1)

• Procedural Success

  30 days

Study Arms (3)

Native mitral valve with severe MAC

EXPERIMENTAL

Patients with symptomatic severe calcific native mitral valve disease with severe mitral annular calcification who have extremely high surgical risk for standard surgical mitral valve replacement, will undergo transcatheter mitral valve replacement.

Device: Transcatheter Mitral Valve Replacement

Valve-in-Ring

EXPERIMENTAL

Patients with symptomatic failing surgical rings resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (valve-in-ring).

Device: Transcatheter Mitral Valve Replacement

Valve-in-Valve

EXPERIMENTAL

Patients with symptomatic failing surgical bioprostheses resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (Valve-in-valve).

Device: Transcatheter Mitral Valve Replacement

Interventions

Transcatheter Mitral Valve Replacement DEVICE

Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.

Native mitral valve with severe MAC; Valve-in-Ring; Valve-in-Valve

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Candidates must meet the following criteria:
• Patient has severe calcific native mitral valve stenosis with mitral annular calcification with echocardiographically derived mitral valve area (MVA) of ≤1.5 cm2, or severe mitral regurgitation with severe mitral annular calcification and at least moderate mitral valve stenosis. Qualifying echo must be within 60 days of the date of the procedure.
• Patient is symptomatic from mitral valve disease, as demonstrated by reported NYHA Functional Class II or greater, or symptoms during stress test.
• The patient is at least 22 years old.
• The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.
• The heart team agrees that medical factors preclude operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the STS score is ≥15% or the probability of death or serious, irreversible morbidity is ≥ 50%. The surgeons' consult notes shall specify the medical or anatomic factors leading to that conclusion and include a printout of the calculation of the STS score to additionally identify the risks in the patient (some medical factors and definitions are provided below). At least one of the cardiac surgeon assessors must have physically evaluated the patient. All patients must be approved by the Patient Selection and Procedure Management Steering Committee (at least 2 member votes, one must be a cardiac surgeon).
• 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 and analysis close date visits, which will be conducted as a phone follow-up.
• All Candidates must meet the following criteria:
• Patient has a failing surgical ring in the mitral position with severe mitral regurgitation or stenosis (echocardiographically derived mitral valve area \[MVA\] of ≤1.5 cm2. Qualifying echo must be within 60 days of the date of the procedure.
• Patient is symptomatic from mitral valve disease, as demonstrated by reported NYHA Functional Class II or greater, or symptoms during stress test, or severe hemolytic anemia requiring blood transfusions and no other cause of hemolytic anemia is found after extensive work up.
• All Candidates must meet the following criteria:
• Patient has a failing surgical bioprosthesis in the mitral position with severe mitral regurgitation or stenosis with echocardiographically derived mitral valve area (MVA) of ≤1.5 cm2. Qualifying echo must be within 60 days of the date of the procedure.
• Patient is symptomatic from mitral valve disease, as demonstrated by reported NYHA Functional Class II or greater, or symptoms during stress test.

You may not qualify if:

• Candidates will be excluded from the study if any of the following conditions are present:
• Heart Team assessment of operability (the heart team considers the patient is a surgical candidate).
• Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment \[defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)\].
• Mitral annulus is not calcified (only applies to patients included in Native MV arm).
• Complex untreated coronary artery disease:
• Unprotected left main coronary artery
• Syntax score \> 32 (in the absence of prior 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 excluded.
• Any patient with a balloon valvuloplasty (BMV) within 30 days of the procedure (unless BMV is a bridge to procedure after a qualifying ECHO).
• Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation.
• Leukopenia (WBC \< 3000 cell/mL), acute anemia (Hgb \< 9 g/dL), Thrombocytopenia (Plt \< 50,000 cell/mL).
• Hypertrophic obstructive cardiomyopathy (HOCM).
• 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 ventricular dysfunction with LVEF \< 20%.

Sponsors & Collaborators

• Mayra Guerrero: lead
• Henry Ford Hospital: collaborator

Study Sites (15)

Banner University Medical Center

Phoenix, Arizona, 85006, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MedStar Washington Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Piedmont HealtCare

Atlanta, Georgia, 30309, United States

Location

Evanston Hospital / North Shore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Memorial Hermann Texas Medical Center

Houston, Texas, 77030, United States

Location

Intermountain Medical Center

Murray, Utah, 48107, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (12)

• Guerrero 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.

  PMID: 24532349 BACKGROUND

• Sinning JM, Mellert F, Schiller W, Welz A, Nickenig G, Hammerstingl C. Transcatheter mitral valve replacement using a balloon-expandable prosthesis in a patient with calcified native mitral valve stenosis. Eur Heart J. 2013 Sep;34(33):2609. doi: 10.1093/eurheartj/eht254. Epub 2013 Jul 4. No abstract available.

  PMID: 23828829 BACKGROUND

• Hasan R, Mahadevan VS, Schneider H, Clarke B. First in human transapical implantation of an inverted transcatheter aortic valve prosthesis to treat native mitral valve stenosis. Circulation. 2013 Aug 6;128(6):e74-6. doi: 10.1161/CIRCULATIONAHA.113.001466. No abstract available.

  PMID: 23918190 BACKGROUND

• Fassa AA, Himbert D, Brochet E, Depoix JP, Cheong AP, Alkhoder S, Nataf P, Vahanian A. Transseptal transcatheter mitral valve implantation for severely calcified mitral stenosis. JACC Cardiovasc Interv. 2014 Jun;7(6):696-7. doi: 10.1016/j.jcin.2013.12.204. Epub 2014 May 14. No abstract available.

  PMID: 24835326 BACKGROUND

• Ribeiro HB, Doyle D, Urena M, Allende R, Amat-Santos I, Pasian S, Bilodeau S, Mohammadi S, Paradis JM, DeLarochelliere R, Rodes-Cabau J, Dumont E. Transapical mitral implantation of a balloon-expandable valve in native mitral valve stenosis in a patient with previous transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2014 Oct;7(10):e137-9. doi: 10.1016/j.jcin.2014.02.024. Epub 2014 Sep 17. No abstract available.

  PMID: 25240553 BACKGROUND

• Ferrari E, Niclauss L, Locca D, Marcucci C. On-pump fibrillating heart mitral valve replacement with the SAPIEN XT transcatheter heart valve. Eur J Cardiothorac Surg. 2014 Apr;45(4):749-51. doi: 10.1093/ejcts/ezt364. Epub 2013 Jul 11.

  PMID: 23847181 BACKGROUND

• Himbert D, Bouleti C, Iung B, Nejjari M, Brochet E, Depoix JP, Ghodbane W, Fassa AA, Nataf P, Vahanian A. Transcatheter valve replacement in patients with severe mitral valve disease and annular calcification. J Am Coll Cardiol. 2014 Dec 16;64(23):2557-8. doi: 10.1016/j.jacc.2014.09.047. No abstract available.

  PMID: 25500243 BACKGROUND

• Guerrero M, Wang DD, Eleid MF, Pursnani A, Salinger M, Russell HM, Kodali SK, George I, Bapat VN, Dangas GD, Tang GHL, Inglesis I, Meduri CU, Palacios I, Reisman M, Whisenant BK, Jermihov A, Kaptzan T, Lewis BR, Tommaso C, Krause P, Thaden J, Oh JK, Douglas PS, Hahn RT, Leon MB, Rihal CS, Feldman T, O'Neill WW. Prospective Study of TMVR Using Balloon-Expandable Aortic Transcatheter Valves in MAC: MITRAL Trial 1-Year Outcomes. JACC Cardiovasc Interv. 2021 Apr 26;14(8):830-845. doi: 10.1016/j.jcin.2021.01.052.

  PMID: 33888229 RESULT

• Guerrero M, Wang DD, Pursnani A, Salinger M, Russell HM, Eleid M, Chakravarty T, Ng MH, Kodali SK, Meduri CU, Pershad A, Satler L, Waksman R, Palacios I, Smalling R, Reisman M, Gegenhuber M, Kaptzan T, Lewis B, Tommaso C, Krause P, Thaden J, Oh J, Douglas PS, Hahn RT, Kar S, Makkar R, Leon MB, Feldman T, Rihal C, O'Neill WW. Prospective Evaluation of TMVR for Failed Surgical Annuloplasty Rings: MITRAL Trial Valve-in-Ring Arm 1-Year Outcomes. JACC Cardiovasc Interv. 2021 Apr 26;14(8):846-858. doi: 10.1016/j.jcin.2021.01.051.

  PMID: 33888230 RESULT

• Guerrero M, Pursnani A, Narang A, Salinger M, Wang DD, Eleid M, Kodali SK, George I, Satler L, Waksman R, Meduri CU, Rajagopal V, Inglessis I, Palacios I, Reisman M, Eng MH, Russell HM, Pershad A, Fang K, Kar S, Makkar R, Saucedo J, Pearson P, Bokhary U, Kaptzan T, Lewis B, Tommaso C, Krause P, Thaden J, Oh J, Lang RM, Hahn RT, Leon MB, O'Neill WW, Feldman T, Rihal C. Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes. JACC Cardiovasc Interv. 2021 Apr 26;14(8):859-872. doi: 10.1016/j.jcin.2021.02.027.

  PMID: 33888231 RESULT

• Guerrero ME, Eleid MF, Wang DD, Pursnani A, Kodali SK, George I, Palacios I, Russell H, Makkar RR, Kar S, Satler LF, Rajagopal V, Dangas G, Tang GHL, McCabe JM, Whisenant BK, Fang K, Balan P, Smalling R, Kaptzan T, Lewis B, Douglas PS, Hahn RT, Thaden J, Oh JK, Leon M, O'Neill W, Rihal C. 5-Year Prospective Evaluation of Mitral Valve-in-Valve, Valve-in-Ring, and Valve-in-MAC Outcomes: MITRAL Trial Final Results. JACC Cardiovasc Interv. 2023 Sep 25;16(18):2211-2227. doi: 10.1016/j.jcin.2023.06.041.

  PMID: 37758379 RESULT

• Sticchi A, Reineke D, Praz F, Windecker S. Transcatheter Mitral Valve Replacement for Mitral Valve-in-Valve, Valve-in-Ring, and Valve-in-MAC Using Balloon-Expandable Transcatheter Heart Valves. JACC Cardiovasc Interv. 2021 Apr 26;14(8):873-878. doi: 10.1016/j.jcin.2021.02.034. No abstract available.

  PMID: 33888232 DERIVED

Related Links

• Mayo Clinic Clinical Trials

Results Point of Contact

• Title: Dr. Mayra Guerrero
• Organization: Mayo Clinic

Guerrero.Mayra@mayo.edu

507-255-1267

Study Officials

• Mayra E. Guerrero, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: February 25, 2015
• Study Start: February 25, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 10, 2023
• Results First Posted: August 16, 2021

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)