Mitral RegurgitationAPOLLO-EUNCT05496998
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
A study testing Medtronic Intrepid™ TMVR TF System in people with Mitral Regurgitation, run by Medtronic Cardiovascular at 37 sites in 8 countries.
Trial summary
Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC who, by agreement of the local site multidisciplinary heart team… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- Medtronic Intrepid™ TMVR TF System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 37 sitesin 8 countries
- Study dates
- 7 Feb 2023to Dec 2038
- Phase
- Interventional
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
- Subject has moderate-to-severe or severe symptomatic mitral regurgitation as defined by the American Society of Echocardiography 2017 Guidelines and Standards - Recommendations for Non-invasive Evaluation of Native Valvular Regurgitation, or subject has moderate symptomatic mitral regurgitation combined with mitral stenosis with the presence of MAC
- Local site multidisciplinary heart team experienced in mitral valve therapies agrees that patient is unsuitable for treatment with approved transcatheter repair or conventional mitral valve surgery
- Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
- Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
- Subjects anatomically suitable for the Medtronic Intrepid™ TMVR TF System
Who cannot join
- Estimated life expectancy of less than 24 months
- Currently surgically implanted mitral valve
- Prior transcatheter mitral valve procedure with device currently implanted
- Anatomic contraindications
- Anatomically prohibitive mitral annular calcification (MAC)
- Aortic valve disease requiring intervention or previous intervention within 90 days of enrollment
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- LVEF < 25% (measured by resting transthoracic echocardiogram), patients with LVEF 25 - <30% will be further evaluated by the Screening Committee for approval (Right Ventricular Dysfunction, pulmonary hypertension, and left ventricular function)
- Left ventricular end diastolic diameter (LVEDD) > 75mm
- Need for emergent or urgent surgery
- Hemodynamic instability
- History of bleeding diathesis or coagulopathy
- End stage renal disease
- Liver failure
- Frailty
Trial locations and contacts
37 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
37 sites in 8 countries
Germany9 sites, 9 recruiting
- Recruiting
Heart and Diabetes Center NRW
Bad Oeynhausen, 32545
Alice Huguette Minko-Nnanga, +49(0)5731973367, hminkonnanga@hdz-nrw.de
Tanja Rudolph, Prof. Dr.
- Recruiting
Deutsches Herzzentrum der Charité (DHZC)
Berlin, 13353
Svetlana Sonnabend, +49(0)3045932270, svetlana.sonnabend@dhzc-charite.de
Jörg Kempfert, Prof. Dr.
- Recruiting
Universitätsklinikum Bonn
Bonn, 53127
Melissa Kirchrath, +49(0)22828714305, melissa.kirchrath@ukbonn.de
Georg Nickenig, Prof. Dr.
- Recruiting
Universitäres Herz- und Gefäßzentrum Hamburg
Hamburg, 20246
Edda Matindas, +49(0)40741052868, e.matindas@uke.de
Yvonne Wittkowski, +49(0)40741051215, y.wittkowski@uke.de
- Recruiting
Herzzentrum Leipzig
Leipzig, 04289
Jospehin Kister, +49(0)3418651584, josephin.kister@helios-health-institute.com
Tobias Kister, Dr.
- Recruiting
University Medical Center Mainz
Mainz, 55131
Janina Mannweiler, +49(0)6131176813, janina.mannweiler@unimedizin-mainz.de
Alexandra Weinel, +49(0)6131176813, alexandra.weinel@unimedizin-mainz.de
- Recruiting
Deutsches Herzzentrum München
München, 80636
Sabine Pronnet, +49(0)8912184030, pronnet@dhm.mhn.de
Hendrik Ruge, Dr.
- Recruiting
LMU Clinic of University Hospital München
München, 81377
Patricia Lempert, +49(0)89440072361, patricia.lempert@med.uni-muenchen.de
Jörg Hausleiter, Prof. Dr.
- Recruiting
Universitätsklinikum Ulm
Ulm, 89081
Theresa Sophie Braun, +49(0)73150045250, theresa.braun@uniklinik-ulm.de
Olga Smirnova, +49(0)73150045009, olga.smirnova@uniklinik-ulm.de
France8 sites, 8 recruiting
- Recruiting
CHU Bordeaux
Bordeaux, Pessac Cedex, 33600
Aurélie Vincent, +33(0)556795679, aurelie.vincent@chu-bordeaux.fr
Thomas Modine, Prof.
- Recruiting
Henri-Mondor University Hospital
Créteil, 94000
Brigitte Bidaud, +33(0)149812265, brigitte.chevalier-bidaud-ext@aphp.fr
Emmanuel Teiger, Prof. Dr.
- Recruiting
CHU Timone
Marseille, 13385
Aurélie Blondelon, +33(0)491386015, aurelie.blondelon@ap-hm.fr
Thomas Cuisset, Prof.
- Recruiting
CHU de Nantes
Nantes, 44093
Marine Renard, +33(0)244768546, marine.renard@chu-nantes.fr
Helena Fettre, +33(0)244768573, helena.fettre@chu-nantes.fr
- Recruiting
CHU Rennes - Pontchaillou Hospital
Rennes, 35033
Pauline Vest, +33(0)299289185, pauline.vest@chu-rennes.fr
Guillaume Leurent, Dr.
- Recruiting
Centre Cardiologique du Nord (CCN)
Saint-Denis, 93200
Karima Moussouni, +33(0)149334141, k.moussouni@ccn.fr
Mohammed Nejjari, Dr.
- Recruiting
Clinique Pasteur
Toulouse, Cedex 03, 31076
Frédéric Petit, +33(0)562213186, fpetit@clinique-pasteur.com
Didier Tchétché, Dr.
- Recruiting
CHRU de Tours
Tours, 37044
Céleste Verne, +33(0)247476913, c.verne@chu-tours.fr
Alexandra Bonnet, +33(0)247476913, a.bonnet@chu-tours.fr
Italy5 sites, 5 recruiting
- Recruiting
Azienda Ospedaliero - Universitaria di Bologna - Policlinico S.Orsola Malpighi
Bologna, 40138
Laura Lombardi, Dr., +39(0)512144475, laura.lombardi15@studio.unibo.it
Francesco Saia, Dr.
- Recruiting
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123
Cristina Gussago, +39(0)303996927, cristina.gussago@unibs.it
Marianna Adamo, Dr.
- Recruiting
Ospedale San Raffaele
Milan, 20132
Davide Schiavi, +39(0)226435316, schiavi.davide@hsr.it
Cosmo Godino, Dr.
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124
Chiara Primerano, +39(0)50994954, chiaraprim@gmail.com
Marco De Carlo, Prof.
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese, 20097
Federica Rossi, +39(0)252774987, federica.rossi@grupposandonato.it
Francesco Bedogni, Prof.
Spain4 sites, 4 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Anna Campos, +34(0)932275519, acampos@clinic.cat
Xavier Freixa, Dr.
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
Paz González, +34(0)913368954, petty.gp@gmail.com
Ángel Recalde, Dr.
- Recruiting
Central University Hospital of Asturias
Oviedo, 33011
Esther Villa Suárez, +34(0)985108000 ext. 36687, lidiaesthervilla@gmail.com
Victor Leon Argûero, Dr.
- Recruiting
University Hospital Alvaro Cunqueiro
Vigo, 36312
Pablo Juan Salvadores, +34(0)986825564, pablo.juan@iisgaliciasur.es
Ana Isabel Ferrero Martinez, +34(0)986825538, ana.ferrero@iisgaliciasur.es
United Kingdom4 sites, 4 recruiting
- Recruiting
University Hospitals Sussex NHS Foundation Trust
Brighton, BN2 5BE
Jessica Parker, +44(0)1273696955 ext. 67950, jessica.parker21@nhs.net
David Hildick-Smith, Prof.
- Recruiting
Leeds General Infirmary
Leeds, LS1 3EX
Shuslim Gurung, +44(0)1135181823, shuslim.gurung@nhs.net
Daniel Blackman, Prof.
- Recruiting
Guys & St Thomas NHS Foundation Trust - St Thomas Hospital London
London, SE1 7EH
Olivia Fox, +44(0)2071887188 ext. 80998/86271, olivia.fox@gstt.nhs.uk
Simon Redwood, Prof.
- Recruiting
Royal Brompton Hospital
London, SW3 6NP
Stefania Sguera, +44(0)2073528121, stefania.sguera1@nhs.net
Marion Dela Cruz, +44(0)3301283422, marion.delacruz@nhs.net
Denmark3 sites, 3 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Elisa Stilling, +45(0)23323386, elisstil@rm.dk
Asger Andersen, Prof.
- Recruiting
Rigshospitalet
Copenhagen, 2100
Signe Pil Scheel Blandford, +45(0)35456485, signe.pil.scheel.blandford@regionh.dk
Ole de Backer, Prof.
- Recruiting
Odense University Hospital
Odense, 5000
Ellen Nyholm Larsen, +45(0)65413716, ellen.nyholm.larsen@rsyd.dk
Henrik Nissen, Dr.
Netherlands3 sites, 3 recruiting
- Recruiting
Catharina Hospital
Eindhoven, 5623 EJ
Harold Helmes, +31(0)402398360, harold.helmes@catharinaziekenhuis.nl
Ingrid Aarts, ingrid.aarts@catharinaziekenhuis.nl
- Recruiting
St. Antonius Hospital
Nieuwegein, 3435 CM
Britt Hopman, +31(0)883201100, b.hopman@antoniusziekenhuis.nl
Martin Swaans, Dr.
- Recruiting
Erasmus University Medical Center
Rotterdam, 3015 AA
Elco van der Heide, +31(0)107032700, e.vanderheide@erasmusmc.nl
Rutger-Jan Nuis, Dr.
Switzerland1 site, 1 recruiting
- Recruiting
Universitätsspital Bern
Bern, 3010
Christina Moro, +41(0)316324476, christina.moro@insel.ch
Stephan Windecker, Prof.Dr.med.
About this study
Official title: Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR Transfemoral System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.
Read the detailed description
Prospective, single-arm, multi-center, interventional, pre-market trial
- Conditions
- Mitral Regurgitation
- Being tested
- Medtronic Intrepid™ TMVR TF System
- Keywords
- mitral, valve, regurgitation, TMVR, Intrepid™, symptomatic, severe
- Medical subject headings
- Mitral Valve Insufficiency, Gastroesophageal Reflux, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Intrepid™ TMVR TF SystemDevice
Patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC will have a Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR Transfemoral System
| Study group | Role | What they receive |
|---|---|---|
| Medtronic Intrepid™ TMVR TF System | Experimental | Medtronic Intrepid™ TMVR TF System Receives: Device: Medtronic Intrepid™ TMVR TF System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: all-cause mortality at 1-year post-procedure.
Rate of all-cause mortality at 1-year post-procedure.
Measured: 1 year
Efficacy: Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure.
Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure as assessed by the Echocardiography Core Laboratory.
Measured: 30 days
Secondary outcomes (9)
Rate of all-cause mortality (Safety).
Rate of all-cause mortality at 30 days post-procedure.
Measured: 30 days
Disabling stroke (Safety).
Rate of disabling stroke at 30 days post-procedure.
Measured: 30 days
Acute Kidney Injury (stage 3 or with renal replacement) (Safety).
Rate of acute kidney injury (stage 3 or with renal replacement) at 30 days post-procedure.
Measured: 30 days
Reoperation or reintervention (Safety).
Rate of reoperation or reintervention at 30 days post-procedure.
Measured: 30 days
Major access site vascular complications (Safety).
Number of major access site vascular complications at 30 days post-procedure.
Measured: 30 days
Mitral valve regurgitation (Efficacy).
Degree of mitral valve regurgitation at 1 year as assessed by the Echocardiography Core Laboratory.
Measured: 1 year
NYHA functional class (Efficacy).
Change in NYHA functional class at 1 year (Efficacy).
Measured: 1 year
Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) (Efficacy).
Change of Quality of Life (QoL) at 1 year as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ scores are scaled from 0 to 100, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Measured: 1 year
Cardiovascular hospitalizations (Efficacy).
Cardiovascular hospitalizations through 1 year (Efficacy).
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 posted11 Aug 2022
- Study start7 Feb 2023
- Primary completionAug 2029 (estimated)
- Study completionDec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Modine, Prof., Principal investigator, University Hospital, Bordeauxvon Bardeleben, Prof., Principal investigator, University Medical Center Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496998
- Sponsor's protocol ID
- MDT22008TMV005
- Acronym
- APOLLO-EU
- Status last verified
- Jul 2026
- First submitted
- 5 Aug 2022
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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