What this study is
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
What's being tested
- Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Intervention · DEVICE
mitral valve replacement
- Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Intervention · DEVICE
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement
Study details
- Official title
- Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial
- Sponsor
- Medtronic Cardiovascular
- Conditions
- Mitral Valve Regurgitation
- Enrolling
- 1,056 people
- Starts
- 2017-10-23
- Est. completion
- 2036-07-07
- Design
- Open-label, non-randomized, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (85)
74 openUniversity of Alabama Birmingham (UAB) Hospital
Birmingham, Alabama, United States
- Marissa Waite · Contact205-659-5660mwaite@uabmc.edu
- Mustafa Ahmed, MD · Principal investigator
- James Davies, MD · Principal investigator
RecruitingAbrazo Heart Hospital
Phoenix, Arizona, United States
- Jessica Byrne · Contact602-952-0002jessica.byrne@abrazohealth.com
- Timothy Byrne, MD · Principal investigator
- Merick Kirshner, MD · Principal investigator
RecruitingPIH Health Good Samaritan Hospital
Los Angeles, California, United States
- Xochitl Quintero · Contact213-977-2121 ext. 2584xochitl.quintero@pihhealth.org
- Steven Burstein · Principal investigator
- Ali Gheissari · Principal investigator
RecruitingKaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
- Elizabeth Castorena · Contact323-383-7383elizabeth.castorena@kp.org
- Somjot Brar, MD · Principal investigator
- Dhaval Trivedi, MD · Principal investigator
RecruitingKeck Hospital of the University of Southern California, USC
Los Angeles, California, United States
- Stephanie Mullin · Contact323-442-6226stephanie.mullin@med.usc.edu
- Vaughn Starnes, MD · Principal investigator
- Ray Vern Matthews, MD · Principal investigator
RecruitingCedars Sinai Medical Center
Los Angeles, California, United States
- Andjela Kremenovic · Contact310-967-0844andjela.kremenovic@cshs.org
- Raj Makkar, MD · Principal investigator
- Wen Cheng, MD · Principal investigator
RecruitingEl Camino Hospital
Mountain View, California, United States
- Mincy Chakkalakal · Contact650-691-4820mincy_chakkalakal@elcaminohealth.org
- Chad Rammohan, MD · Principal investigator
- Vincent Gaudiani, MD · Principal investigator
RecruitingKaiser Permanente San Francisco Medical Center
San Francisco, California, United States
- Elizabeth Castorena · Contact323-383-7383elizabeth.castorena@kp.org
- Ahmad Sheikh, MD · Principal investigator
- Andrew Rassi, MD · Principal investigator
RecruitingStanford Hospital and Clinics
Stanford, California, United States
- Kokil Bakshi · Contact650-206-0140kbakshi@stanford.edu
- David Lee, MD · Principal investigator
- Jack Boyd, MD · Principal investigator
RecruitingLos Robles Regional Medical Center
Thousand Oaks, California, United States
- Mane Arabyan · Contact805-796-3746mane.arabyan@hcahealthcare.com
- Saibal Kar, MD · Principal investigator
- Gregory Fontana, ND · Principal investigator
RecruitingHartford Hospital
Hartford, Connecticut, United States
- Jill Cloutier · Contact860-972-2579jill.cloutier@hhchealth.org
- Talhat Azemi, MD · Principal investigator
- Sabet Hashim · Principal investigator
- Robert Hagberg · Principal investigator
RecruitingYale New Haven Hospital
New Haven, Connecticut, United States
- Linda Levesque · Contact203-737-6483Linda.levesque@yale.edu
- John Forrest, MD · Principal investigator
- Prashanth Vallabhajosyula, MD · Principal investigator
RecruitingJFK Medical Center
Atlantis, Florida, United States
- Mailer Fonseca · Contact561-358-9998mailer.fonseca@HCAhealthcare.com
- Mark Rothenberg, MD · Principal investigator
- Cristiano Faber, MD · Principal investigator
RecruitingMorton Plant
Clearwater, Florida, United States
- Sue Fisher · Contact727-462-7574susan.fisher1@baycare.org
- Lang L Lin, MD · Principal investigator
- Joshua J Rovin, MD · Principal investigator
RecruitingHealthPark Medical Center
Fort Myers, Florida, United States
- Michelle Deckard · Contact239-343-5074michelle.deckard@leehealth.org
- Murali Muppala, MD · Principal investigator
- Daniel O'Hair, MD · Principal investigator
RecruitingNorth Florida Regional Medical Center
Gainesville, Florida, United States
- Danielle Murrhee · Contact352-244-0208demurrhee@tcavi.com
- Ilie Barb, MD · Principal investigator
- Charles Klodell, MD · Principal investigator
RecruitingBaptist Medical Center Jacksonville
Jacksonville, Florida, United States
- Doran Byers · Contact904-202-7218doran.byers@bmcjax.com
- Ruby Satpahy, MD · Principal investigator
- Nathan Bates, MD · Principal investigator
RecruitingUniversity of South Florida Health
Tampa, Florida, United States
- Mia Eifrid · Contact813-395-2194miaeifrid@usf.edu
- Hiram Bezerra, MD · Principal investigator
- Lucian Lozonschi, MD · Principal investigator
RecruitingEmory University
Atlanta, Georgia, United States
- Elizabeth Charles · Contact404-686-1249elizabeth.z.charles@emory.edu
- Adam Greenbaum, MD · Principal investigator
- Gaetano Paone, MD · Principal investigator
RecruitingPiedmont Atlanta Hospital
Atlanta, Georgia, United States
- Danielle Griffith · Contact470-633-2183danielle.griffith@piedmont.org
- Pradeep Yadav, MD · Principal investigator
- Thourani Vinod, MD · Principal investigator
RecruitingNorthwestern Memorial Hospital
Chicago, Illinois, United States
- Justin Cortez · Contact312-926-4000justin.cortez@nm.org
- S. Chris Malaisrie, MD · Principal investigator
- Charles Davidson, MD · Principal investigator
RecruitingRush University Medical Center
Chicago, Illinois, United States
- Gaurav Dhar, MD · Contact312-942-5020gaurav_dhar@rush.edu
- Hussam Suradi, MD · Principal investigator
- Antone Tatooles, MD · Principal investigator
RecruitingMercyOne Des Moines Medical Center
Des Moines, Iowa, United States
- Kendra Tuttle · Contact515-235-5102ktuttle@iowaheart.com
- Donna J. Prouty · Contact515-633-3848donna.prouty@mercyoneiowa.org
- Atul Chawla, MD · Principal investigator
- Bart Jenson, MD · Principal investigator
RecruitingUniversity of Kansas Medical Center
Kansas City, Kansas, United States
- Terry Christenson · Contact913-588-5687tchristenson3@kumc.edu
- Mark Wiley, MD · Principal investigator
- Emmanuel Daon, MD · Principal investigator
RecruitingThe Johns Hopkins Hospital
Baltimore, Maryland, United States
- Michele Fisher · Contact410-955-6839mfishe26@jhmi.edu
- Rani Hasan, MD · Principal investigator
- Hamza Aziz, MD · Principal investigator
RecruitingMassachusetts General Hospital
Boston, Massachusetts, United States
- Lina Fu · Contact617-643-1371lfu2@partners.org
- Ignacio Inglessis, MD · Principal investigator
- Serguei Melnitchouk, MD · Principal investigator
RecruitingBrigham and Women's Hospital
Boston, Massachusetts, United States
- Julie Anderson · Contact617-525-7044janderson58@bwh.harvard.edu
- Pinak Bipin Shah, MD · Principal investigator
- Ashraf Sabe, MD · Principal investigator
RecruitingBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
- Jenifer Kaufman · Contact617-632-8956jmkaufma@bidmc.harvard.edu
- Roger Laham, MD · Principal investigator
- David Liu, MD · Principal investigator
RecruitingUniversity of Michigan Health System
Ann Arbor, Michigan, United States
- Keoni Fordham · Contact734-763-6551fordham@med.umich.edu
- Stanley Chetcuti, MD · Principal investigator
- Steven Bolling, MD · Principal investigator
RecruitingHenry Ford Saint John Hospital
Detroit, Michigan, United States
- Renee Bess · Contact313-343-4811rbess1@hfhs.org
- Theodore Schreiber, MD · Principal investigator
- Sanjay Batra, MD · Principal investigator
RecruitingCorewell Health
Grand Rapids, Michigan, United States
- Elizabeth Helm · Contact616-486-2080elizabeth.helm@corewellhealth.org
- William Merhi, MD · Principal investigator
- Stephane Leung, MD · Principal investigator
RecruitingAbbott Northwestern Hospital
Minneapolis, Minnesota, United States
- Jason Digman · Contact612-863-3996jason.digman@allina.com
- Vinayak Bapat, MD · Principal investigator
- Mario Goessl, MD · Principal investigator
RecruitingM Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota, United States
- Melanie Farinella · Contact612-626-4611crawl027@umn.edu
- Gregory Helmer, MD · Principal investigator
- Rochus Voeller, MD · Principal investigator
RecruitingBarnes-Jewish Hospital
St Louis, Missouri, United States
- Kim Striler · Contact314-747-4452kstriler@wustl.edu
- Alan Zajarias, MD · Principal investigator
- Puja Kachroo, MD · Principal investigator
RecruitingProvidence St Patrick
Missoula, Montana, United States
- Christina Michael · Contact406-329-2792christina.michael@providence.org
- Travis Abicht, MD · Principal investigator
- James Maddux, MD · Principal investigator
RecruitingMorristown Medical Center
Morristown, New Jersey, United States
- Catherine Van Zile · Contact973-971-5951catherine.vanzile@alantichealth.org
- Philippe Genereux, MD · Principal investigator
- John Brown, MD · Principal investigator
RecruitingJersey Shore University Medical Center
Neptune City, New Jersey, United States
- Anne DeToro · Contact732-776-3499annemarie.detoro@hmhn.org
- Matthew Saybolt · Principal investigator
RecruitingNorthwell Health North Shore University Hospital
Manhasset, New York, United States
- Kristine McGowan · Contact516-562-2345kmcgowan@northwell.edu
- Bruce Rutkin, MD · Principal investigator
- Sheel Vatsia, MD · Principal investigator
RecruitingNYU Langone Medical Center
New York, New York, United States
- Sara Hanahan · Contact929-989-5764sara.hanahan@nyulangone.org
- Matthew Williams, MD · Principal investigator
- Cezar Staniloae, MD · Principal investigator
RecruitingThe Mount Sinai Hospital
New York, New York, United States
- Favio Herbas · Contact212-241-9914favio.herbas@mountsinai.org
- Samin Sharma, MD · Principal investigator
- David Adams, MD · Principal investigator
RecruitingNew York-Presbyterian Hospital Columbia University Medical Center
New York, New York, United States
- Kate Dalton · Contact347-514-3366keb2114@cumc.columbia.edu
- Isaac George, MD · Principal investigator
- Tamim Nazif, MD · Principal investigator
RecruitingMontefiore Medical Center
New York, New York, United States
- Angela Yang · Contact718-920-6431anyang@montefiore.org
- Azeem Latib, MD · Principal investigator
- Tadahisa Sugiura, MD · Principal investigator
RecruitingSaint Francis Hospital
Roslyn, New York, United States
- Patricia Krug · Contact516-562-6790patricia.krug@chsli.org
- Joan Jennings · Contact516-562-6790joan.jennings@chsli.org
- George Petrossian, MD · Principal investigator
- Newell Robinson, MD · Principal investigator
RecruitingThe Christ Hospital
Cincinnati, Ohio, United States
- Marien Bryson · Contact513-585-1777marien.bryson@thechristhospital.com
- Puvi Seshiah, MD · Principal investigator
- Geoffrey Answini, MD · Principal investigator
RecruitingUniversity Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
- Nisreen Zueiter · Contact216-844-3801nisreen.zueiter@uhhospitals.org
- Guilherme Attizzani, MD · Principal investigator
- Mohamed Abdel Halim, MN · Principal investigator
RecruitingThe Ohio State University Wexner Medical Center
Columbus, Ohio, United States
- Annie Kellum · Contact740-341-9808annie.kellum@osumc.edu
- Konstantinos Boudoulas, MD · Principal investigator
- Bryan Whitson, MD · Principal investigator
RecruitingOhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States
- Martha Slyman · Contact614-566-1274martha.slyman@ohiohealth.com
- Steven Yakubov, MD · Principal investigator
- Jefferson Lyons, MD · Principal investigator
RecruitingIntegris Baptist Medical Center
Oklahoma City, Oklahoma, United States
- Jill Fife · Contact405-951-8607bethany.fife@integrisok.com
- Jeffrey Sparling, MD · Principal investigator
- Craig Elkins, MD · Principal investigator
RecruitingProvidence Saint Vincent Medical Center
Portland, Oregon, United States
- Angela Redd · Contact503-216-2170angela.redd@providence.org
- Brandon Jones, MD · Principal investigator
- Eric Kirker, MD · Principal investigator
RecruitingOregon Health & Science University Hospital
Portland, Oregon, United States
- Sarah Pellicer · Contact612-554-1787pellicer@ohsu.edu
- Firas Zahr, MD · Principal investigator
- Howard Song, MD · Principal investigator
RecruitingUPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania, United States
- Brittany Mashuda · Contact240-575-8789mashudabd@upmc.edu
- Arun Kanmanthareddy, MD · Principal investigator
- Mubashir Mumtaz, MD · Principal investigator
RecruitingUPMC Presbyterian
Pittsburgh, Pennsylvania, United States
- Kristin Konopka · Contact412-647-7271valcharka@upmc.edu
- Conrad Smith, MD · Principal investigator
- Derek Serna-Gallegos, MD · Principal investigator
RecruitingLankenau Medical Center
Wynnewood, Pennsylvania, United States
- Joyce Jung · Contact484-476-8570chenste@mlhs.org
- Scott S Goldman, MD · Principal investigator
- William W Gray, MD · Principal investigator
- Basel Ramlawi, MD · Principal investigator
RecruitingVanderbilt University Medical Center
Nashville, Tennessee, United States
- Natalie Jackson · Contact615-343-1782natalie.jackson@vumc.org
- Tarek Absi, MD · Principal investigator
- Colin Barker, MD · Principal investigator
RecruitingHeart Hospital of Austin
Austin, Texas, United States
- Shir Yelovitch · Contact512-459-3300shir.yelovitch@stdavids.com
- John Moscona, MD · Principal investigator
- Faraz Kerendi, MD · Principal investigator
RecruitingTexas Health Presbyterian Hospital Dallas
Dallas, Texas, United States
- Evan Porter · Contact214-345-4387evanporter@texashealth.org
- James Park, MD · Principal investigator
- Brandon Hill, MD · Principal investigator
RecruitingCHI Saint Luke's Health-Baylor Saint Luke's Medical Center
Houston, Texas, United States
- Zaida Bisbal · Contact713-798-5568zaida.bisbal2@bcm.edu
- Guilherme Silva, MD · Principal investigator
- Joseph Coselli, MD · Principal investigator
RecruitingHouston Methodist Hospital
Houston, Texas, United States
- Tia McGaughy · Contact346-238-4576tsmcgaughy@houstonmethodist.org
- Neal Kleiman, MD · Principal investigator
- Michael Reardon, MD · Principal investigator
RecruitingThe University of Texas Health Science Center at Houston
Houston, Texas, United States
- Anna Menezes · Contact713-500-6569anna.m.menezes@uth.tmc.edu
- Richard Smalling, MD · Principal investigator
- Anthony Estrera, MD · Principal investigator
RecruitingThe Heart Hospital Baylor Plano
Plano, Texas, United States
- Jasmine Kennedy · Contact469-814-4732jasmine.kennedy@bswhealth.org
- Molly Szerlip, MD · Principal investigator
- Robert Smith, DM · Principal investigator
RecruitingMethodist Hospital
San Antonio, Texas, United States
- Laura Gravino · Contact210-575-7865laura.gravino@hcahealthcare.com
- Jorge Alvarez, MD · Principal investigator
- James Garrison, MD · Principal investigator
RecruitingThe University of Vermont Medical Center
Burlington, Vermont, United States
- Amy Henderson · Contact802-847-4746amy.henderson@uvmhealth.org
- Harold Dauerman, MD · Principal investigator
- Fuyuki Hirashima, MD · Principal investigator
RecruitingUniversity of Virginia Medical Center
Charlottesville, Virginia, United States
- Christin Henderson · Contact434-531-2777cap5j@virginia.edu
- John Saxon, MD · Principal investigator
- Leora Yarboro, MD · Principal investigator
RecruitingInova Fairfax Hospital
Fairfax, Virginia, United States
- Diana McLean · Contact703-776-3367diana.mclean@inova.org
- Shahram Yazdani, MD · Principal investigator
- Eric Sarin, MD · Principal investigator
RecruitingSentara Norfolk General Hospital
Norfolk, Virginia, United States
- Christine Calayo · Contact757-388-3876cacalayo@sentara.com
- Matthew Summers, MD · Principal investigator
- Clinton Kemp, MN · Principal investigator
RecruitingUniversity of Washington (UW) Medical Center
Seattle, Washington, United States
- John Tushinski · Contact206-685-4346jtushin@uw.edu
- Christine Chung, MD · Principal investigator
- Scott DeRoo, MD · Principal investigator
RecruitingProvidence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, United States
- Lauren Wilcox · Contact604-521-4500lauren.wilcox@providence.org
- Jonathan Hansen, MD · Principal investigator
- Matthew Forrester, MD · Principal investigator
RecruitingAurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
- Dena Burke · Contact414-649-3490Dena.Burke@aah.org
- Tanvir Bajwa, MD · Principal investigator
- William Fischer, MD · Principal investigator
RecruitingScripps Memorial Hospital
La Jolla, California, United States
Active, not recruitingMedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Active, not recruitingUniversity of Maryland Medical Center
Baltimore, Maryland, United States
CompletedNYU Langone Hospital - Long Island
Mineola, New York, United States
Active, not recruitingDuke University Medical Center
Durham, North Carolina, United States
WithdrawnBaylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, United States
WithdrawnSaint Mary's Hospital/Bon Secours
Richmond, Virginia, United States
WithdrawnCarilion Roanoke Memorial Hospital
Roanoke, Virginia, United States
WithdrawnWinchester Medical Center
Winchester, Virginia, United States
Active, not recruitingThe Swedish Medical Center Cherry Hill
Seattle, Washington, United States
Withdrawn
7 sites outside the US
Royal Columbian Hospital
New Westminster, British Columbia, Canada
- Lauren Samis · Contact604-521-4500lsamis@fraserclinicaltrials.com
- Razi Khan, MD · Principal investigator
- Shahzad Karim, MD · Principal investigator
RecruitingSaint Paul's Hospital
Vancouver, British Columbia, Canada
- Tanja Kot · Contact604-806-8804tkot@providencehealth.bc.ca
- David Wood, MD · Principal investigator
- Anson Cheung, MD · Principal investigator
RecruitingSunnybrook Health Sciences Centre
Toronto, Ontario, Canada
- Mary Li · Contact416-480-6100mli@sri.utoronto.ca
- Andrew Czarnecki, MD · Principal investigator
- Gideon Cohen, MD · Principal investigator
RecruitingSaint Michael's Hospital
Toronto, Ontario, Canada
- Ivana Kandic · Contact416-360-4000 ext. 49003ivana.kandic@unityhealth.to
- Neil Fam, MD · Principal investigator
- Gianluigi Bisleri, MD · Principal investigator
RecruitingMontreal Heart Insitute
Montreal, Quebec, Canada
- Sophie Robichaud · Contact514-376-3330 ext. 3305sophie.robichaud@icm-mhi.org
- Ralph Stephan von Bardeleben, MD · Principal investigator
- Walid Ben Ali, MD · Principal investigator
RecruitingGlen Royal Victoria Hospital
Montreal, Quebec, Canada
- Thi Mong Ngoc Phan · Contact514-934-1934 ext. 36147thimongngoc.phan@muhc.mcgill.ca
- Nicolo Piazza · Principal investigator
- Benoit de Varennes · Principal investigator
RecruitingRigshospitalet
Copenhagen, Denmark
Withdrawn
Study team
Sponsor
Medtronic Cardiovascular
Study ID MDT17022TMV001
Study chair
Michael Mack, MD
Baylor Scott & White Hospital
Principal investigator
David Adams, MD
Icahn School of Medicine at Mount Sinai
Principal investigator
Martin Leon, MD
New York Presbyterian Hospital/Columbia University Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.