Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
APOLLO-EU
1 other identifier
interventional
400
8 countries
37
Brief 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 experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Longer than P75 for not_applicable
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2022
CompletedFirst Posted
Study publicly available on registry
August 11, 2022
CompletedStudy Start
First participant enrolled
February 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2038
December 17, 2025
December 1, 2025
6.5 years
August 5, 2022
December 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety: all-cause mortality at 1-year post-procedure.
Rate of all-cause mortality at 1-year post-procedure.
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.
30 days
Secondary Outcomes (9)
Rate of all-cause mortality (Safety).
30 days
Disabling stroke (Safety).
30 days
Acute Kidney Injury (stage 3 or with renal replacement) (Safety).
30 days
Reoperation or reintervention (Safety).
30 days
Major access site vascular complications (Safety).
30 days
- +4 more secondary outcomes
Study Arms (1)
Medtronic Intrepid™ TMVR TF System
EXPERIMENTALMedtronic Intrepid™ TMVR TF System
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Aarhus University Hospital
Aarhus, 8200, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Odense University Hospital
Odense, 5000, Denmark
Clinique Pasteur
Toulouse, Cedex 03, 31076, France
CHU Bordeaux
Bordeaux, Pessac Cedex, 33600, France
Henri-Mondor University Hospital
Créteil, 94000, France
CHU Timone
Marseille, 13385, France
CHU de Nantes
Nantes, 44093, France
CHU Rennes - Pontchaillou Hospital
Rennes, 35033, France
Centre Cardiologique du Nord (CCN)
Saint-Denis, 93200, France
CHRU de Tours
Tours, 37044, France
Heart and Diabetes Center NRW
Bad Oeynhausen, 32545, Germany
Deutsches Herzzentrum der Charité (DHZC)
Berlin, 13353, Germany
Universitätsklinikum Bonn
Bonn, 53127, Germany
Universitäres Herz- und Gefäßzentrum Hamburg
Hamburg, 20246, Germany
Herzzentrum Leipzig
Leipzig, 04289, Germany
University Medical Center Mainz
Mainz, 55131, Germany
Deutsches Herzzentrum München
München, 80636, Germany
LMU Clinic of University Hospital München
München, 81377, Germany
Universitätsklinikum Ulm
Ulm, 89081, Germany
Azienda Ospedaliero - Universitaria di Bologna - Policlinico S.Orsola Malpighi
Bologna, 40138, Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124, Italy
IRCCS Policlinico San Donato
San Donato Milanese, 20097, Italy
Catharina Hospital
Eindhoven, 5623 EJ, Netherlands
St. Antonius Hospital
Nieuwegein, 3435 CM, Netherlands
Erasmus University Medical Center
Rotterdam, 3015 AA, Netherlands
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Central University Hospital of Asturias
Oviedo, 33011, Spain
University Hospital Alvaro Cunqueiro
Vigo, 36312, Spain
Universitätsspital Bern
Bern, 3010, Switzerland
University Hospitals Sussex NHS Foundation Trust
Brighton, BN2 5BE, United Kingdom
Leeds General Infirmary
Leeds, LS1 3EX, United Kingdom
Guys & St Thomas NHS Foundation Trust - St Thomas Hospital London
London, SE1 7EH, United Kingdom
Royal Brompton Hospital
London, SW3 6NP, United Kingdom
Related Publications (1)
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.
PMID: 41251714DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Modine, Prof.
University Hospital, Bordeaux
- PRINCIPAL INVESTIGATOR
von Bardeleben, Prof.
University Medical Center Mainz
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2022
First Posted
August 11, 2022
Study Start
February 7, 2023
Primary Completion (Estimated)
August 1, 2029
Study Completion (Estimated)
December 1, 2038
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share