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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 38 sites in 8 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

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
38 sitesin 8 countries
Study dates
7 Feb 2023to Dec 2038
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

  • 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
Show all 14Show fewer
  • 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

38 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Hanne Gonnissen, PhD contact

+31 (0)43 356 6566

rs.apolloeurope@medtronic.com

38 sites in 8 countries

Germany10 sites, 10 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

  • University Hospital Cologne

    Cologne, 50937

    Vera Wolf, +49(0)22147832592, vera.wolf@uk-koeln.de

    Lenard Conradi, 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

    Recruiting

Other trials in Germany

France8 sites, 8 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

    Recruiting

Other trials in France

Italy5 sites, 5 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.

    Recruiting

Other trials in Italy

Spain4 sites, 4 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

    Recruiting

Other trials in Spain

United Kingdom4 sites, 4 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

    Recruiting

Other trials in United Kingdom

Denmark3 sites, 3 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.

    Recruiting

Other trials in Denmark

Netherlands3 sites, 3 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.

    Recruiting

Other trials in Netherlands

Switzerland1 site, 1 recruiting

  • Universitätsspital Bern

    Bern, 3010

    Christina Moro, +41(0)316324476, christina.moro@insel.ch

    Stephan Windecker, Prof.Dr.med.

    Recruiting

Other trials in Switzerland

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

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 groups in NCT05496998
Study groupRoleWhat they receive
Medtronic Intrepid™ TMVR TF SystemExperimentalMedtronic 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.

  1. Safety: all-cause mortality at 1-year post-procedure.

    Rate of all-cause mortality at 1-year post-procedure.

    Measured: 1 year

  2. 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)

  1. Rate of all-cause mortality (Safety).

    Rate of all-cause mortality at 30 days post-procedure.

    Measured: 30 days

  2. Disabling stroke (Safety).

    Rate of disabling stroke at 30 days post-procedure.

    Measured: 30 days

  3. 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

  4. Reoperation or reintervention (Safety).

    Rate of reoperation or reintervention at 30 days post-procedure.

    Measured: 30 days

  5. Major access site vascular complications (Safety).

    Number of major access site vascular complications at 30 days post-procedure.

    Measured: 30 days

  6. Mitral valve regurgitation (Efficacy).

    Degree of mitral valve regurgitation at 1 year as assessed by the Echocardiography Core Laboratory.

    Measured: 1 year

  7. NYHA functional class (Efficacy).

    Change in NYHA functional class at 1 year (Efficacy).

    Measured: 1 year

  8. 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

  9. 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.

  1. First posted11 Aug 2022
  2. Study start7 Feb 2023
  3. Primary completionAug 2029 (estimated)
  4. Study completionDec 2038 (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
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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05496998
Sponsor's protocol ID
MDT22008TMV005
Acronym
APOLLO-EU
Status last verified
Oct 2026
First submitted
5 Aug 2022
Last updated
30 Oct 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

Questions about this trial

What is this clinical trial studying?

A study testing Medtronic Intrepid™ TMVR TF System in people with Mitral Regurgitation, run by Medtronic Cardiovascular at 38 sites in 8 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 5 inclusion and 14 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 38 sites in Germany, France, Italy, Spain, United Kingdom and 3 more countries. 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 Hanne Gonnissen, PhD (+31 (0)43 356 6566, rs.apolloeurope@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: all-cause mortality at 1-year post-procedure. (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 NCT05496998, 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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