Actively Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Led by Medtronic Cardiovascular · Updated on 2025-12-17
400
Participants Needed
37
Research Sites
825 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Moderate-to-severe or severe symptomatic mitral regurgitation as defined by the American Society of Echocardiography 2017 Guidelines, or moderate symptomatic mitral regurgitation with mitral stenosis and presence of mitral annular calcification
- Deemed unsuitable for approved transcatheter repair or conventional mitral valve surgery by a local multidisciplinary heart team experienced in mitral valve therapies
- Agreement by subject and treating physician to attend all required post-procedure follow-up visits
- Meets legal minimum age to provide informed consent based on local regulations
- Anatomically suitable for the Medtronic Intrepid212 TMVR Transfemoral System
You will not qualify if you...
- Estimated life expectancy less than 24 months
- Currently has a surgically implanted mitral valve
- Prior transcatheter mitral valve procedure with a device currently implanted
- Anatomic contraindications to the procedure
- Anatomically prohibitive mitral annular calcification
- Aortic valve disease requiring or having had intervention within 90 days prior to enrollment
- Left ventricular ejection fraction below 25%; patients with 25 to below 30% need further screening approval
- Left ventricular end diastolic diameter greater than 75 mm
- Need for emergent or urgent surgery
- Hemodynamic instability
- History of bleeding diathesis or coagulopathy
- End stage renal disease
- Liver failure
- Frailty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 37 locations
1
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
2
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
3
Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
4
Clinique Pasteur
Toulouse, Cedex 03, France, 31076
Actively Recruiting
5
CHU Bordeaux
Bordeaux, Pessac Cedex, France, 33600
Actively Recruiting
6
Henri-Mondor University Hospital
Créteil, France, 94000
Actively Recruiting
7
CHU Timone
Marseille, France, 13385
Actively Recruiting
8
CHU de Nantes
Nantes, France, 44093
Actively Recruiting
9
CHU Rennes - Pontchaillou Hospital
Rennes, France, 35033
Actively Recruiting
10
Centre Cardiologique du Nord (CCN)
Saint-Denis, France, 93200
Actively Recruiting
11
CHRU de Tours
Tours, France, 37044
Actively Recruiting
12
Heart and Diabetes Center NRW
Bad Oeynhausen, Germany, 32545
Actively Recruiting
13
Deutsches Herzzentrum der Charité (DHZC)
Berlin, Germany, 13353
Actively Recruiting
14
Universitätsklinikum Bonn
Bonn, Germany, 53127
Actively Recruiting
15
Universitäres Herz- und Gefäßzentrum Hamburg
Hamburg, Germany, 20246
Actively Recruiting
16
Herzzentrum Leipzig
Leipzig, Germany, 04289
Actively Recruiting
17
University Medical Center Mainz
Mainz, Germany, 55131
Actively Recruiting
18
Deutsches Herzzentrum München
München, Germany, 80636
Actively Recruiting
19
LMU Clinic of University Hospital München
München, Germany, 81377
Actively Recruiting
20
Universitätsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
21
Azienda Ospedaliero - Universitaria di Bologna - Policlinico S.Orsola Malpighi
Bologna, Italy, 40138
Actively Recruiting
22
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy, 25123
Actively Recruiting
23
Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
24
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56124
Actively Recruiting
25
IRCCS Policlinico San Donato
San Donato Milanese, Italy, 20097
Actively Recruiting
26
Catharina Hospital
Eindhoven, Netherlands, 5623 EJ
Actively Recruiting
27
St. Antonius Hospital
Nieuwegein, Netherlands, 3435 CM
Actively Recruiting
28
Erasmus University Medical Center
Rotterdam, Netherlands, 3015 AA
Actively Recruiting
29
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
30
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
31
Central University Hospital of Asturias
Oviedo, Spain, 33011
Actively Recruiting
32
University Hospital Alvaro Cunqueiro
Vigo, Spain, 36312
Actively Recruiting
33
Universitätsspital Bern
Bern, Switzerland, 3010
Actively Recruiting
34
University Hospitals Sussex NHS Foundation Trust
Brighton, United Kingdom, BN2 5BE
Actively Recruiting
35
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
Actively Recruiting
36
Guys & St Thomas NHS Foundation Trust - St Thomas Hospital London
London, United Kingdom, SE1 7EH
Actively Recruiting
37
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Actively Recruiting
Research Team
H
Hanne Gonnissen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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