AzTrials
AzTrials

Mitral Valve RegurgitationAPOLLONCT03242642

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.

A study testing Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) in people with Mitral Valve Regurgitation, run by Medtronic Cardiovascular at 85 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mitral Valve Regurgitation
What is being tested?
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,056 participants
Where
85 sitesin 3 countries
Study dates
23 Oct 2017to 7 Jul 2036
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

  • Moderate to severe or severe symptomatic mitral regurgitation
  • Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention

Who cannot join

  • prior transcatheter mitral valve procedure with device currently implanted
  • anatomic contraindications
  • prohibitive mitral annular calcification
  • left ventricular ejection fraction <25%
  • need for emergent or urgent surgery
  • hemodynamic instability

Trial locations and contacts

85 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Megan Wilder Fredrickson contact

612-469-1749

rs.tmvrpivotaltrial@medtronic.com

85 sites in 3 countries

United States78 sites, 68 recruiting

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

    Keoni Fordham, 734-763-6551, fordham@med.umich.edu

    Stanley Chetcuti, MD

    Recruiting

  • Emory University

    Atlanta, Georgia, 30308

    Elizabeth Charles, 404-686-1249, elizabeth.z.charles@emory.edu

    Adam Greenbaum, MD

    Recruiting

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30309

    Danielle Griffith, 470-633-2183, danielle.griffith@piedmont.org

    Pradeep Yadav, MD

    Recruiting

  • JFK Medical Center

    Atlantis, Florida, 33462

    Mailer Fonseca, 561-358-9998, mailer.fonseca@HCAhealthcare.com

    Mark Rothenberg, MD

    Recruiting

  • Heart Hospital of Austin

    Austin, Texas, 78756

    Shir Yelovitch, 512-459-3300, shir.yelovitch@stdavids.com

    John Moscona, MD

    Recruiting

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

    Completed

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287

    Michele Fisher, 410-955-6839, mfishe26@jhmi.edu

    Rani Hasan, MD

    Recruiting

  • University of Alabama Birmingham (UAB) Hospital

    Birmingham, Alabama, 35233

    Marissa Waite, 205-659-5660, mwaite@uabmc.edu

    Mustafa Ahmed, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Lina Fu, 617-643-1371, lfu2@partners.org

    Ignacio Inglessis, MD

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Julie Anderson, 617-525-7044, janderson58@bwh.harvard.edu

    Pinak Bipin Shah, MD

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Jenifer Kaufman, 617-632-8956, jmkaufma@bidmc.harvard.edu

    Roger Laham, MD

    Recruiting

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401-1473

    Amy Henderson, 802-847-4746, amy.henderson@uvmhealth.org

    Harold Dauerman, MD

    Recruiting

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

    Christin Henderson, 434-531-2777, cap5j@virginia.edu

    John Saxon, MD

    Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

    Justin Cortez, 312-926-4000, justin.cortez@nm.org

    S. Chris Malaisrie, MD

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Gaurav Dhar, MD, 312-942-5020, gaurav_dhar@rush.edu

    Hussam Suradi, MD

    Recruiting

  • The Christ Hospital

    Cincinnati, Ohio, 45219-2906

    Marien Bryson, 513-585-1777, marien.bryson@thechristhospital.com

    Puvi Seshiah, MD

    Recruiting

  • Morton Plant

    Clearwater, Florida, 33756

    Sue Fisher, 727-462-7574, susan.fisher1@baycare.org

    Lang L Lin, MD

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Nisreen Zueiter, 216-844-3801, nisreen.zueiter@uhhospitals.org

    Guilherme Attizzani, MD

    Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

    Annie Kellum, 740-341-9808, annie.kellum@osumc.edu

    Konstantinos Boudoulas, MD

    Recruiting

  • OhioHealth Riverside Methodist Hospital

    Columbus, Ohio, 43214

    Martha Slyman, 614-566-1274, martha.slyman@ohiohealth.com

    Steven Yakubov, MD

    Recruiting

  • Texas Health Presbyterian Hospital Dallas

    Dallas, Texas, 75231

    Evan Porter, 214-345-4387, evanporter@texashealth.org

    James Park, MD

    Recruiting

  • Baylor Jack and Jane Hamilton Heart and Vascular Hospital

    Dallas, Texas, 75246

    Withdrawn

  • MercyOne Des Moines Medical Center

    Des Moines, Iowa, 50314

    Kendra Tuttle, 515-235-5102, ktuttle@iowaheart.com

    Donna J. Prouty, 515-633-3848, donna.prouty@mercyoneiowa.org

    Recruiting

  • Henry Ford Saint John Hospital

    Detroit, Michigan, 48236

    Renee Bess, 313-343-4811, rbess1@hfhs.org

    Theodore Schreiber, MD

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Withdrawn

  • Inova Fairfax Hospital

    Fairfax, Virginia, 22042

    Diana McLean, 703-776-3367, diana.mclean@inova.org

    Shahram Yazdani, MD

    Recruiting

  • HealthPark Medical Center

    Fort Myers, Florida, 33908

    Michelle Deckard, 239-343-5074, michelle.deckard@leehealth.org

    Murali Muppala, MD

    Recruiting

  • North Florida Regional Medical Center

    Gainesville, Florida, 32605

    Danielle Murrhee, 352-244-0208, demurrhee@tcavi.com

    Ilie Barb, MD

    Recruiting

  • Corewell Health

    Grand Rapids, Michigan, 49503

    Elizabeth Helm, 616-486-2080, elizabeth.helm@corewellhealth.org

    William Merhi, MD

    Recruiting

  • UPMC Pinnacle Harrisburg Campus

    Harrisburg, Pennsylvania, 17101

    Brittany Mashuda, 240-575-8789, mashudabd@upmc.edu

    Arun Kanmanthareddy, MD

    Recruiting

  • Hartford Hospital

    Hartford, Connecticut, 06102

    Jill Cloutier, 860-972-2579, jill.cloutier@hhchealth.org

    Talhat Azemi, MD

    Recruiting

  • CHI Saint Luke's Health-Baylor Saint Luke's Medical Center

    Houston, Texas, 77030

    Zaida Bisbal, 713-798-5568, zaida.bisbal2@bcm.edu

    Guilherme Silva, MD

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Tia McGaughy, 346-238-4576, tsmcgaughy@houstonmethodist.org

    Neal Kleiman, MD

    Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Anna Menezes, 713-500-6569, anna.m.menezes@uth.tmc.edu

    Richard Smalling, MD

    Recruiting

  • Baptist Medical Center Jacksonville

    Jacksonville, Florida, 32207

    Doran Byers, 904-202-7218, doran.byers@bmcjax.com

    Ruby Satpahy, MD

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Terry Christenson, 913-588-5687, tchristenson3@kumc.edu

    Mark Wiley, MD

    Recruiting

  • Scripps Memorial Hospital

    La Jolla, California, 92037

    Active, not recruiting

  • PIH Health Good Samaritan Hospital

    Los Angeles, California, 90017

    Xochitl Quintero, 213-977-2121 ext. 2584, xochitl.quintero@pihhealth.org

    Steven Burstein

    Recruiting

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

    Elizabeth Castorena, 323-383-7383, elizabeth.castorena@kp.org

    Somjot Brar, MD

    Recruiting

  • Keck Hospital of the University of Southern California, USC

    Los Angeles, California, 90033

    Stephanie Mullin, 323-442-6226, stephanie.mullin@med.usc.edu

    Vaughn Starnes, MD

    Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    Andjela Kremenovic, 310-967-0844, andjela.kremenovic@cshs.org

    Raj Makkar, MD

    Recruiting

  • Northwell Health North Shore University Hospital

    Manhasset, New York, 11030

    Kristine McGowan, 516-562-2345, kmcgowan@northwell.edu

    Bruce Rutkin, MD

    Recruiting

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

    Dena Burke, 414-649-3490, Dena.Burke@aah.org

    Tanvir Bajwa, MD

    Recruiting

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

    Active, not recruiting

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

    Jason Digman, 612-863-3996, jason.digman@allina.com

    Vinayak Bapat, MD

    Recruiting

  • M Health Fairview University of Minnesota Medical Center - East Bank

    Minneapolis, Minnesota, 55455

    Melanie Farinella, 612-626-4611, crawl027@umn.edu

    Gregory Helmer, MD

    Recruiting

  • Providence St Patrick

    Missoula, Montana, 59802-4008

    Christina Michael, 406-329-2792, christina.michael@providence.org

    Travis Abicht, MD

    Recruiting

  • Morristown Medical Center

    Morristown, New Jersey, 07960

    Catherine Van Zile, 973-971-5951, catherine.vanzile@alantichealth.org

    Philippe Genereux, MD

    Recruiting

  • El Camino Hospital

    Mountain View, California, 94040

    Mincy Chakkalakal, 650-691-4820, mincy_chakkalakal@elcaminohealth.org

    Chad Rammohan, MD

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37203

    Natalie Jackson, 615-343-1782, natalie.jackson@vumc.org

    Tarek Absi, MD

    Recruiting

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

    Anne DeToro, 732-776-3499, annemarie.detoro@hmhn.org

    Matthew Saybolt

    Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

    Linda Levesque, 203-737-6483, Linda.levesque@yale.edu

    John Forrest, MD

    Recruiting

  • NYU Langone Medical Center

    New York, New York, 10016

    Sara Hanahan, 929-989-5764, sara.hanahan@nyulangone.org

    Matthew Williams, MD

    Recruiting

  • The Mount Sinai Hospital

    New York, New York, 10029

    Favio Herbas, 212-241-9914, favio.herbas@mountsinai.org

    Samin Sharma, MD

    Recruiting

  • New York-Presbyterian Hospital Columbia University Medical Center

    New York, New York, 10032

    Kate Dalton, 347-514-3366, keb2114@cumc.columbia.edu

    Isaac George, MD

    Recruiting

  • Montefiore Medical Center

    New York, New York, 10467-2401

    Angela Yang, 718-920-6431, anyang@montefiore.org

    Azeem Latib, MD

    Recruiting

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507-1904

    Christine Calayo, 757-388-3876, cacalayo@sentara.com

    Matthew Summers, MD

    Recruiting

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112

    Jill Fife, 405-951-8607, bethany.fife@integrisok.com

    Jeffrey Sparling, MD

    Recruiting

  • Abrazo Heart Hospital

    Phoenix, Arizona, 85018

    Jessica Byrne, 602-952-0002, jessica.byrne@abrazohealth.com

    Timothy Byrne, MD

    Recruiting

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213

    Kristin Konopka, 412-647-7271, valcharka@upmc.edu

    Conrad Smith, MD

    Recruiting

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093

    Jasmine Kennedy, 469-814-4732, jasmine.kennedy@bswhealth.org

    Molly Szerlip, MD

    Recruiting

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

    Angela Redd, 503-216-2170, angela.redd@providence.org

    Brandon Jones, MD

    Recruiting

  • Oregon Health & Science University Hospital

    Portland, Oregon, 97239

    Sarah Pellicer, 612-554-1787, pellicer@ohsu.edu

    Firas Zahr, MD

    Recruiting

  • Saint Mary's Hospital/Bon Secours

    Richmond, Virginia, 23226

    Withdrawn

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24014

    Withdrawn

  • Saint Francis Hospital

    Roslyn, New York, 11576

    Patricia Krug, 516-562-6790, patricia.krug@chsli.org

    Joan Jennings, 516-562-6790, joan.jennings@chsli.org

    Recruiting

  • Methodist Hospital

    San Antonio, Texas, 78229

    Laura Gravino, 210-575-7865, laura.gravino@hcahealthcare.com

    Jorge Alvarez, MD

    Recruiting

  • Kaiser Permanente San Francisco Medical Center

    San Francisco, California, 94118-3100

    Elizabeth Castorena, 323-383-7383, elizabeth.castorena@kp.org

    Ahmad Sheikh, MD

    Recruiting

  • The Swedish Medical Center Cherry Hill

    Seattle, Washington, 98122

    Withdrawn

  • University of Washington (UW) Medical Center

    Seattle, Washington, 98195

    John Tushinski, 206-685-4346, jtushin@uw.edu

    Christine Chung, MD

    Recruiting

  • Providence Sacred Heart Medical Center & Children's Hospital

    Spokane, Washington, 99204

    Lauren Wilcox, 604-521-4500, lauren.wilcox@providence.org

    Jonathan Hansen, MD

    Recruiting

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110-1003

    Kim Striler, 314-747-4452, kstriler@wustl.edu

    Alan Zajarias, MD

    Recruiting

  • Stanford Hospital and Clinics

    Stanford, California, 94305

    Kokil Bakshi, 650-206-0140, kbakshi@stanford.edu

    David Lee, MD

    Recruiting

  • University of South Florida Health

    Tampa, Florida, 33606

    Mia Eifrid, 813-395-2194, miaeifrid@usf.edu

    Hiram Bezerra, MD

    Recruiting

  • Los Robles Regional Medical Center

    Thousand Oaks, California, 91360-1847

    Mane Arabyan, 805-796-3746, mane.arabyan@hcahealthcare.com

    Saibal Kar, MD

    Recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    Active, not recruiting

  • Winchester Medical Center

    Winchester, Virginia, 22601

    Active, not recruiting

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

    Joyce Jung, 484-476-8570, chenste@mlhs.org

    Scott S Goldman, MD

    Recruiting

Other trials in United States

Canada6 sites, 6 recruiting

  • Montreal Heart Insitute

    Montreal, Quebec, H1T 1C8

    Sophie Robichaud, 514-376-3330 ext. 3305, sophie.robichaud@icm-mhi.org

    Ralph Stephan von Bardeleben, MD

    Recruiting

  • Glen Royal Victoria Hospital

    Montreal, Quebec, H4A 3J1

    Thi Mong Ngoc Phan, 514-934-1934 ext. 36147, thimongngoc.phan@muhc.mcgill.ca

    Nicolo Piazza

    Recruiting

  • Royal Columbian Hospital

    New Westminster, British Columbia, V3L 3W7

    Lauren Samis, 604-521-4500, lsamis@fraserclinicaltrials.com

    Razi Khan, MD

    Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Mary Li, 416-480-6100, mli@sri.utoronto.ca

    Andrew Czarnecki, MD

    Recruiting

  • Saint Michael's Hospital

    Toronto, Ontario, M5B 1W8

    Ivana Kandic, 416-360-4000 ext. 49003, ivana.kandic@unityhealth.to

    Neil Fam, MD

    Recruiting

  • Saint Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

    Tanja Kot, 604-806-8804, tkot@providencehealth.bc.ca

    David Wood, MD

    Recruiting

Other trials in Canada

Denmark1 site

  • Rigshospitalet

    Copenhagen, 2100

    Withdrawn

Other trials in Denmark

About this study

Official title: Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial

Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.

Being tested
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Keywords
Heart disease, valve disease, heart valve disease, mitral regurgitation, cardiovascular disease, mitral insufficiency
Medical subject headings
Mitral Valve Insufficiency, Heart Diseases, Heart Valve Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)Device

    mitral valve replacement

  • Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)Device

    Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement

Study groups in NCT03242642
Study groupRoleWhat they receive
Primary Cohort- TMVRExperimentalTreatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
Receives: Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Mitral Annular Calcification -TMVRExperimentalTreatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
Receives: Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Cohort

    Composite of all-cause mortality or heart failure hospitalization

    Measured: 1 year

  2. MAC Cohort

    All-cause mortality

    Measured: 1 year

Secondary outcomes (6)

  1. All-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation or reintervention, and major bleeding

    Composite

    Measured: 30 days or hospital discharge (whichever is later)

  2. Degree of mitral regurgitation

    measured by echocardiography

    Measured: 6 months

  3. Quality of Life Improvement

    measured by KCCQ

    Measured: 3 months (KCCQ)

  4. Change in New York Heart Association Class

    change in NYHA Class

    Measured: 30 days

  5. Echocardiographic assessments of degree mitral valve regurgitation

    measured by echocardiography

    Measured: 1 year

  6. Cardiovascular hospitalizations

    cardiovascular hospitalizations

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2017
  2. Study start23 Oct 2017
  3. Primary completionJun 2027 (estimated)
  4. Study completion7 Jul 2036 (estimated)

Resources

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
Single group
Masking
None (open label)
Enrolment
1,056 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03242642
Sponsor's protocol ID
MDT17022TMV001
Acronym
APOLLO
Status last verified
Oct 2026
First submitted
3 Aug 2017
Last updated
30 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Tang GHL, Rajagopal V, Sorajja P, Bajwa T, Gooley R, Walton A, Modine T, Ng MK, Williams MR, Zajarias A, Hildick-Smith D, Tchetche D, Spargias K, Rajani R, Bapat VN, De Backer O, Blackman D, McCarthy P, Laine M, Jain R, Martin R, Thaden JJ, Marka NA, Mack M, Adams DH, Leon MB, Reardon MJ. Five-year outcomes of the early-generation Intrepid transapical transcatheter mitral valve replacement system. EuroIntervention. 2026 Feb 2;22(3):e172-e182. doi: 10.4244/EIJ-D-25-01133.

    PubMed 41251714

Questions about this trial

What is this clinical trial studying?

A study testing Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) in people with Mitral Valve Regurgitation, run by Medtronic Cardiovascular at 85 sites in 3 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 2 inclusion and 6 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 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Canada, Denmark. 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 Megan Wilder Fredrickson (612-469-1749, rs.tmvrpivotaltrial@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Cohort (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT03242642, which also lists 1 linked publication.

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 30 Oct 2026.

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