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
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- 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)
Studienstandort
Bern
(BASEC)
Sponsor
Medtronic Schweiz AG
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Stephan Windecker
+41 31 632 44 97
stephan.windecker@clutterinsel.chInselspital, Universitätsspital Bern
(BASEC)
Allgemeine Auskünfte
CHU Bordeaux,University Medical Center Mainz,
+31 (0)43 356 6566
rs.apolloeurope@medtronic.com(ICTRP)
Allgemeine Auskünfte
University Hospital, BordeauxUniversity Medical Center Mainz
+31 (0)43 356 6566
rs.apolloeurope@medtronic.com(ICTRP)
Wissenschaftliche Auskünfte
CHU Bordeaux,University Medical Center Mainz,
+31 (0)43 356 6566
rs.apolloeurope@medtronic.com(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
02.05.2023
(BASEC)
ICTRP Studien-ID
NCT05496998 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Transcatheter Mitral Valve Replacement with the Medtronic Intrepid TMVR Transfemoral System in patients with severe symptomatic mitral regurgitation – APOLLO-EU Trial (BASEC)
Wissenschaftlicher Titel
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid TMVR Transfemoral System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial (ICTRP)
Öffentlicher Titel
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial (ICTRP)
Untersuchte Krankheit(en)
Mitral Regurgitation (ICTRP)
Untersuchte Intervention
Device: Medtronic Intrepid TMVR TF System (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
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)
Sekundäre IDs
MDT22008TMV005 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT05496998 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar