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Recruiting NCT05496998

Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

No phase Interventional Mitral Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medtronic Intrepid™ TMVR TF System.
Who it may be relevant to
Registry conditions: Mitral Regurgitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark, France, Germany, Italy, Netherlands +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR Transfemoral System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

Overview

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

Interventions

  • Device Medtronic Intrepid™ TMVR TF System
    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

Primary outcome measures

  • Safety: all-cause mortality at 1-year post-procedure. [Time frame: 1 year]
  • Efficacy: Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure. [Time frame: 30 days]
Secondary outcome measures (9)
  • Rate of all-cause mortality (Safety). [Time frame: 30 days]
  • Disabling stroke (Safety). [Time frame: 30 days]
  • Acute Kidney Injury (stage 3 or with renal replacement) (Safety). [Time frame: 30 days]
  • Reoperation or reintervention (Safety). [Time frame: 30 days]
  • Major access site vascular complications (Safety). [Time frame: 30 days]
  • Mitral valve regurgitation (Efficacy). [Time frame: 1 year]
  • NYHA functional class (Efficacy). [Time frame: 1 year]
  • Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) (Efficacy). [Time frame: 1 year]
  • Cardiovascular hospitalizations (Efficacy). [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 9 centers
  • Heart and Diabetes Center NRW — Bad Oeynhausen
  • Deutsches Herzzentrum der Charité (DHZC) — Berlin
  • Universitätsklinikum Bonn — Bonn
  • Universitäres Herz- und Gefäßzentrum Hamburg — Hamburg
  • Herzzentrum Leipzig — Leipzig
  • University Medical Center Mainz — Mainz
  • Deutsches Herzzentrum München — München
  • LMU Clinic of University Hospital München — München
  • … and 1 more center
France · 8 centers
  • Clinique Pasteur — Toulouse
  • CHU Bordeaux — Bordeaux
  • Henri-Mondor University Hospital — Créteil
  • CHU Timone — Marseille
  • CHU de Nantes — Nantes
  • CHU Rennes - Pontchaillou Hospital — Rennes
  • Centre Cardiologique du Nord (CCN) — Saint-Denis
  • CHRU de Tours — Tours
Italy · 5 centers
  • Azienda Ospedaliero - Universitaria di Bologna - Policlinico S.Orsola Malpighi — Bologna
  • Azienda Ospedaliera Spedali Civili di Brescia — Brescia
  • Ospedale San Raffaele — Milan
  • Azienda Ospedaliero Universitaria Pisana — Pisa
  • IRCCS Policlinico San Donato — San Donato Milanese
Spain · 4 centers
  • Hospital Clínic de Barcelona — Barcelona
  • Hospital Universitario Ramón y Cajal — Madrid
  • Central University Hospital of Asturias — Oviedo
  • University Hospital Alvaro Cunqueiro — Vigo
United Kingdom · 4 centers
  • University Hospitals Sussex NHS Foundation Trust — Brighton
  • Leeds General Infirmary — Leeds
  • Guys & St Thomas NHS Foundation Trust - St Thomas Hospital London — London
  • Royal Brompton Hospital — London
Denmark · 3 centers
  • Aarhus University Hospital — Aarhus
  • Rigshospitalet — Copenhagen
  • Odense University Hospital — Odense
Netherlands · 3 centers
  • Catharina Hospital — Eindhoven
  • St. Antonius Hospital — Nieuwegein
  • Erasmus University Medical Center — Rotterdam
Switzerland · 1 center
  • Universitätsspital Bern — Bern

Publications

  • 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. PMID 41251714

Identifiers

NCT: NCT05496998 · MDT22008TMV005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗