Less invasive replacement of a severely leaking heart valve with the Intrepid system from Medtronic Full title: Catheter-assisted mitral valve replacement with the Intrepid™ TMVR Transfemoral System from Medtronic in patients with severe symptomatic mitral valve insufficiency – APOLLO-EU study
Descrizione riassuntiva dello studio
Patient enrollment in the study will begin in 2023 and is expected to last 28 months. Study participants will be followed for about 10 years from the time of implantation of the Intrepid™ heart valve. Approximately 400 patients will participate in the study in Europe. In Switzerland, about 15 patients will participate in this study. As part of the examination, the investigator will schedule 19 hospital visits and 8 phone appointments with the patients: During the pre-examination, tests will be conducted to confirm that the patients are eligible to participate. During the implantation visit, the actual procedure, the catheter-assisted mitral valve replacement, will take place. The Intrepid™ valve implant will be advanced in a capsule through a long flexible tube (catheter) through an opening in the groin and a large vein to the heart. A small opening will be created in the heart wall through which the catheter and capsule will be introduced into the heart and the Intrepid™ valve can be placed in the mitral valve. The empty capsule and catheter will then be removed and the opening in the groin will be closed. Study data will be collected from each patient at discharge from the hospital, after 30 days, after 3 months, after 6 months, and once a year until the end of the 10-year follow-up period.
(BASEC)
Intervento studiato
A treatment for mitral valve insufficiency is the replacement of the leaking mitral valve with an artificial heart valve during open-heart surgery. Another option is the repair of the leaflets, either through an open-heart procedure or through a product (clip) that is implanted using a catheter (inserted into the heart through a leg vein via a long, flexible tube (introducer catheter)) that 'clips' the leaflets of the mitral valve. Both methods are currently the standard treatment methods for moderate to severe mitral valve insufficiency.
The Intrepid™ TMVR-TF system studied in this study was developed as an alternative to standard open-heart surgery to replace a diseased mitral valve without open-heart surgery. With this system, a bioprosthetic mitral valve (Intrepid™ valve) can be implanted (inserted) through a long, thin, flexible tube that is introduced through an incision in the groin and through a vein in the leg.
(BASEC)
Malattie studiate
Moderate to severe or severe symptomatic mitral valve insufficiency (leakage in the heart valve), unsuitable for surgical mitral valve repair or surgical mitral valve replacement or an approved catheter-assisted repair.
(BASEC)
- The study participant suffers from moderate to severe or severe symptomatic mitral valve insufficiency according to the guidelines and standards of the American Society of Echocardiography 2017 - Recommendations for Non-invasive Evaluation of Native Valvular Regurgitation or moderate symptomatic mitral valve insufficiency in combination with mitral stenosis in the presence of a MAC. - The local multidisciplinary heart team with experience in mitral valve therapy agrees that the patient is not suitable for catheter-assisted repair or conventional mitral valve surgery. - Study participants who are anatomically suitable for the Intrepid™ TMVR TF system from Medtronic. (BASEC)
Criteri di esclusione
- Estimated life expectancy of less than 24 months due to an existing condition not related to the heart. - Currently existing surgically implanted mitral valve - Anatomical contraindications for the Intrepid™ TMVR TF system from Medtronic (e.g., dimensions of the valve opening, high risk of partial or complete obstruction of the left ventricle outflow tract, access, etc.) (BASEC)
Luogo dello studio
Berna
(BASEC)
Sponsor
Medtronic Schweiz AG
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Stephan Windecker
+41 31 632 44 97
stephan.windecker@clutterinsel.chInselspital, Universitätsspital Bern
(BASEC)
Informazioni generali
CHU Bordeaux,University Medical Center Mainz,
+31 (0)43 356 6566
rs.apolloeurope@medtronic.com(ICTRP)
Informazioni generali
University Hospital, BordeauxUniversity Medical Center Mainz
+31 (0)43 356 6566
rs.apolloeurope@medtronic.com(ICTRP)
Informazioni scientifiche
CHU Bordeaux,University Medical Center Mainz,
+31 (0)43 356 6566
rs.apolloeurope@medtronic.com(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
02.05.2023
(BASEC)
ID di studio ICTRP
NCT05496998 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Transcatheter Mitral Valve Replacement with the Medtronic Intrepid TMVR Transfemoral System in patients with severe symptomatic mitral regurgitation – APOLLO-EU Trial (BASEC)
Titolo accademico
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid TMVR Transfemoral System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial (ICTRP)
Titolo pubblico
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial (ICTRP)
Malattie studiate
Mitral Regurgitation (ICTRP)
Intervento studiato
Device: Medtronic Intrepid TMVR TF System (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 (ICTRP)
non disponibile
Endpoint primari e secondari
Safety: all-cause mortality at 1-year post-procedure.;Efficacy: Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure. (ICTRP)
Rate of all-cause mortality (Safety).;Disabling stroke (Safety).;Acute Kidney Injury (stage 3 or with renal replacement) (Safety).;Reoperation or reintervention (Safety).;Major access site vascular complications (Safety).;Mitral valve regurgitation (Efficacy).;NYHA functional class (Efficacy).;Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) (Efficacy).;Cardiovascular hospitalizations (Efficacy). (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Thomas Modine, Prof.;von Bardeleben, Prof.;Hanne Gonnissen, PhD, rs.apolloeurope@medtronic.com, +31 (0)43 356 6566, CHU Bordeaux,University Medical Center Mainz, (ICTRP)
ID secondari
MDT22008TMV005 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT05496998 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile