Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
- Conditions
- Mitral Regurgitation
- Interventions
- Device: Medtronic Intrepid™ TMVR TF System
- Registration Number
- NCT05496998
- Lead Sponsor
- Medtronic Cardiovascular
- 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.
- Detailed Description
Prospective, single-arm, multi-center, interventional, pre-market trial
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Medtronic Intrepid™ TMVR TF System Medtronic Intrepid™ TMVR TF System Medtronic Intrepid™ TMVR TF System
- Primary Outcome Measures
Name Time Method Efficacy: Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure. 30 days Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure as assessed by the Echocardiography Core Laboratory.
Safety: all-cause mortality at 1-year post-procedure. 1 year Rate of all-cause mortality at 1-year post-procedure.
- Secondary Outcome Measures
Name Time Method Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) (Efficacy). 1 year 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.
Rate of all-cause mortality (Safety). 30 days Rate of all-cause mortality at 30 days post-procedure.
Disabling stroke (Safety). 30 days Rate of disabling stroke at 30 days post-procedure.
Acute Kidney Injury (stage 3 or with renal replacement) (Safety). 30 days Rate of acute kidney injury (stage 3 or with renal replacement) at 30 days post-procedure.
Major access site vascular complications (Safety). 30 days Number of major access site vascular complications at 30 days post-procedure.
NYHA functional class (Efficacy). 1 year Change in NYHA functional class at 1 year (Efficacy).
Reoperation or reintervention (Safety). 30 days Rate of reoperation or reintervention at 30 days post-procedure.
Mitral valve regurgitation (Efficacy). 1 year Degree of mitral valve regurgitation at 1 year as assessed by the Echocardiography Core Laboratory.
Cardiovascular hospitalizations (Efficacy). 1 year Cardiovascular hospitalizations through 1 year (Efficacy).
Trial Locations
- Locations (33)
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Rigshospitalet
🇩🇰Copenhagen, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
Clinique Pasteur
🇫🇷Toulouse, Cedex 03, France
CHU Bordeaux
🇫🇷Bordeaux, Pessac Cedex, France
Henri-Mondor University Hospital
🇫🇷Créteil, France
CHU Timone
🇫🇷Marseille, France
CHU de Nantes
🇫🇷Nantes, France
CHU Rennes - Pontchaillou Hospital
🇫🇷Rennes, France
Centre Cardiologique du Nord (CCN)
🇫🇷Saint-Denis, France
CHRU de Tours
🇫🇷Tours, France
Heart and Diabetes Center NRW
🇩🇪Bad Oeynhausen, Germany
Deutsches Herzzentrum der Charité (DHZC)
🇩🇪Berlin, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Universitäres Herz- und Gefäßzentrum Hamburg
🇩🇪Hamburg, Germany
Herzzentrum Leipzig
🇩🇪Leipzig, Germany
University Medical Center Mainz
🇩🇪Mainz, Germany
Deutsches Herzzentrum München
🇩🇪München, Germany
LMU Clinic of University Hospital München
🇩🇪München, Germany
Azienda Ospedaliero - Universitaria di Bologna - Policlinico S.Orsola Malpighi
🇮🇹Bologna, Italy
Ospedale San Raffaele
🇮🇹Milan, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
IRCCS Policlinico San Donato
🇮🇹San Donato Milanese, Italy
Catharina Hospital
🇳🇱Eindhoven, Netherlands
St. Antonius Hospital
🇳🇱Nieuwegein, Netherlands
Erasmus University Medical Center
🇳🇱Rotterdam, Netherlands
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Central University Hospital of Asturias
🇪🇸Oviedo, Spain
Universitätsspital Bern
🇨🇭Bern, Switzerland
University Hospitals Sussex NHS Foundation Trust
🇬🇧Brighton, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
Guys & St Thomas NHS Foundation Trust - St Thomas Hospital London
🇬🇧London, United Kingdom
Royal Brompton Hospital
🇬🇧London, United Kingdom