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

December 12, 2025 updated by: Medtronic Cardiovascular

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prospective, single-arm, multi-center, interventional, pre-market trial

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital
        • Contact:
        • Principal Investigator:
          • Asger Andersen, Prof.
        • Principal Investigator:
          • Christian Alcarez Frederiksen, Dr.
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Rigshospitalet
        • Contact:
        • Principal Investigator:
          • Ole De Backer, Prof.
        • Principal Investigator:
          • Jacob Møller, Prof.
      • Odense, Denmark, 5000
        • Recruiting
        • Odense University Hospital
        • Contact:
        • Principal Investigator:
          • Henrik Nissen, Dr.
        • Principal Investigator:
          • Tina Homayounfar Leetmaa, Dr.
  • France
      • Créteil, France, 94000
        • Recruiting
        • Henri-Mondor University Hospital
        • Contact:
        • Principal Investigator:
          • Emmanuel Teiger, Prof. Dr.
        • Principal Investigator:
          • Thierry Folliguet, Prof. Dr.
      • Marseille, France, 13385
        • Recruiting
        • CHU Timone
        • Contact:
        • Principal Investigator:
          • Thomas Cuisset, Prof.
        • Principal Investigator:
          • Pierre Morera, Dr.
      • Nantes, France, 44093
        • Recruiting
        • CHU de Nantes
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thibaut Manigold, Dr.
        • Principal Investigator:
          • Jean-Christian Roussel, Prof.
      • Rennes, France, 35033
        • Recruiting
        • CHU Rennes - Pontchaillou Hospital
        • Contact:
        • Principal Investigator:
          • Guillaume Leurent, Dr.
        • Principal Investigator:
          • Hervé Corbineau, Prof.
      • Saint-Denis, France, 93200
        • Recruiting
        • Centre Cardiologique du Nord (CCN)
        • Contact:
        • Principal Investigator:
          • Mohammed Nejjari, Dr.
        • Principal Investigator:
          • Nicolas Bonnet, Dr.
      • Tours, France, 37044
        • Recruiting
        • CHRU de Tours
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christophe Saint Etienne, Dr.
        • Principal Investigator:
          • Thierry Bourguignon, Prof.
    • Cedex 03
      • Toulouse, Cedex 03, France, 31076
        • Recruiting
        • Clinique Pasteur
        • Contact:
        • Principal Investigator:
          • Didier Tchétché, Dr.
        • Principal Investigator:
          • Pierre Berthoumieu, Dr.
    • Pessac Cedex
      • Bordeaux, Pessac Cedex, France, 33600
        • Recruiting
        • CHU Bordeaux
        • Principal Investigator:
          • Thomas Modine, Prof.
        • Principal Investigator:
          • Lionel Leroux, Dr.
        • Contact:
  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Recruiting
        • Heart and Diabetes Center NRW
        • Contact:
        • Principal Investigator:
          • Sabine Bleiziffer, Prof. Dr.
        • Principal Investigator:
          • Tanja Rudolph, Prof. Dr.
      • Berlin, Germany, 13353
        • Recruiting
        • Deutsches Herzzentrum der Charité (DHZC)
        • Contact:
        • Principal Investigator:
          • Jörg Kempfert, Prof. Dr.
        • Principal Investigator:
          • Christoph Klein, Dr.
      • Bonn, Germany, 53127
        • Recruiting
        • Universitätsklinikum Bonn
        • Principal Investigator:
          • Georg Nickenig, Prof. Dr.
        • Contact:
        • Principal Investigator:
          • Wilhelm Röll, Prof. Dr.
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitäres Herz- und Gefäßzentrum Hamburg
        • Contact:
        • Contact:
        • Principal Investigator:
          • Niklas Schofer, Dr. med.
        • Principal Investigator:
          • Andreas Schäfer, Prof. Dr. med.
      • Leipzig, Germany, 04289
        • Recruiting
        • Herzzentrum Leipzig
        • Contact:
        • Principal Investigator:
          • Holger Thiele, Prof. Dr.
        • Principal Investigator:
          • Thilo Noack, PD Dr. med.
      • Mainz, Germany, 55131
        • Recruiting
        • University Medical Center Mainz
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ralph Stephan von Bardeleben, Prof. Dr.
        • Principal Investigator:
          • Hendrik Treede, Prof. Dr.
      • München, Germany, 80636
        • Recruiting
        • Deutsches Herzzentrum München
        • Contact:
        • Principal Investigator:
          • Hendrik Ruge, Dr.
        • Principal Investigator:
          • Erion Xhepa, Dr.
      • München, Germany, 81377
        • Recruiting
        • LMU Clinic of University Hospital München
        • Contact:
        • Principal Investigator:
          • Jörg Hausleiter, Prof. Dr.
        • Principal Investigator:
          • Sven Peterß, Dr.
      • Ulm, Germany, 89081
        • Recruiting
        • Universitätsklinikum Ulm
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wolfgang Rottbauer, Prof. Dr. med.
        • Principal Investigator:
          • Andreas Liebold, Prof. Dr. med.
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • Azienda Ospedaliero - Universitaria di Bologna - Policlinico S.Orsola Malpighi
        • Contact:
        • Principal Investigator:
          • Francesco Saia, Dr.
        • Principal Investigator:
          • Alessandro Leone, Dr.
      • Brescia, Italy, 25123
        • Recruiting
        • Azienda Ospedaliera Spedali Civili di Brescia
        • Contact:
        • Principal Investigator:
          • Marianna Adamo, Dr.
        • Principal Investigator:
          • Paolo Piccoli, Dr.
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele
        • Contact:
        • Principal Investigator:
          • Cosmo Godino, Dr.
        • Principal Investigator:
          • Francesco Maisano, Prof.
      • Pisa, Italy, 56124
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
        • Contact:
        • Principal Investigator:
          • Marco De Carlo, Prof.
        • Principal Investigator:
          • Andrea Colli, Prof.
      • San Donato Milanese, Italy, 20097
        • Recruiting
        • IRCCS Policlinico San Donato
        • Contact:
        • Principal Investigator:
          • Francesco Bedogni, Prof.
        • Principal Investigator:
          • Carlo De Vincentiis, Dr.
  • Netherlands
      • Eindhoven, Netherlands, 5623 EJ
      • Nieuwegein, Netherlands, 3435 CM
        • Recruiting
        • St. Antonius Hospital
        • Contact:
        • Principal Investigator:
          • Martin Swaans, Dr.
        • Principal Investigator:
          • Leo Timmers, Dr.
      • Rotterdam, Netherlands, 3015 AA
        • Recruiting
        • Erasmus University Medical Center
        • Principal Investigator:
          • Nicolas van Mieghem, Prof.
        • Contact:
        • Principal Investigator:
          • Jolanda Kluin, Prof.
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Contact:
        • Principal Investigator:
          • Xavier Freixa, Dr.
        • Principal Investigator:
          • Marta Sitges, Dr.
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal
        • Contact:
        • Principal Investigator:
          • Ángel Recalde, Dr.
        • Principal Investigator:
          • José Luis Zamorano, Dr.
      • Oviedo, Spain, 33011
        • Recruiting
        • Central University Hospital of Asturias
        • Contact:
        • Principal Investigator:
          • Victor Leon Argûero, Dr.
        • Principal Investigator:
          • Isaac Pascual, Dr.
      • Vigo, Spain, 36312
        • Recruiting
        • University Hospital Alvaro Cunqueiro
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rodrigo Estevez Loureiro, Dr.
        • Principal Investigator:
          • Manuel Barreiro Perez, Dr.
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Universitätsspital Bern
        • Contact:
        • Principal Investigator:
          • David Reineke, Dr. med.
        • Principal Investigator:
          • Stephan Windecker, Prof.Dr.med.
  • United Kingdom
      • Brighton, United Kingdom, BN2 5BE
        • Recruiting
        • University Hospitals Sussex NHS Foundation Trust
        • Principal Investigator:
          • David Hildick-Smith, Prof.
        • Contact:
        • Principal Investigator:
          • Uday Trivedi, Mr.
      • Leeds, United Kingdom, LS1 3EX
        • Recruiting
        • Leeds General Infirmary
        • Contact:
        • Principal Investigator:
          • Daniel Blackman, Prof.
        • Principal Investigator:
          • Betsy Evans, Miss
      • London, United Kingdom, SW3 6NP
        • Recruiting
        • Royal Brompton Hospital
        • Contact:
        • Principal Investigator:
          • Alison Duncan, Dr.
        • Principal Investigator:
          • Ee Ling Heng, Dr.
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • Guys & St Thomas NHS Foundation Trust - St Thomas Hospital London
        • Contact:
        • Principal Investigator:
          • Simon Redwood, Prof.
        • Principal Investigator:
          • Gianluca Lucchese, Mr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medtronic Intrepid™ TMVR TF System
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: all-cause mortality at 1-year post-procedure.
Time Frame: 1 year
Rate of all-cause mortality at 1-year post-procedure.
1 year
Efficacy: Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure.
Time Frame: 30 days
Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure as assessed by the Echocardiography Core Laboratory.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of all-cause mortality (Safety).
Time Frame: 30 days
Rate of all-cause mortality at 30 days post-procedure.
30 days
Disabling stroke (Safety).
Time Frame: 30 days
Rate of disabling stroke at 30 days post-procedure.
30 days
Acute Kidney Injury (stage 3 or with renal replacement) (Safety).
Time Frame: 30 days
Rate of acute kidney injury (stage 3 or with renal replacement) at 30 days post-procedure.
30 days
Reoperation or reintervention (Safety).
Time Frame: 30 days
Rate of reoperation or reintervention at 30 days post-procedure.
30 days
Major access site vascular complications (Safety).
Time Frame: 30 days
Number of major access site vascular complications at 30 days post-procedure.
30 days
Mitral valve regurgitation (Efficacy).
Time Frame: 1 year
Degree of mitral valve regurgitation at 1 year as assessed by the Echocardiography Core Laboratory.
1 year
NYHA functional class (Efficacy).
Time Frame: 1 year
Change in NYHA functional class at 1 year (Efficacy).
1 year
Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) (Efficacy).
Time Frame: 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.
1 year
Cardiovascular hospitalizations (Efficacy).
Time Frame: 1 year
Cardiovascular hospitalizations through 1 year (Efficacy).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiovascular

Investigators

  • Principal Investigator: Thomas Modine, Prof., University Hospital, Bordeaux
  • Principal Investigator: von Bardeleben, Prof., University Medical Center Mainz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2023

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

December 1, 2038

Study Registration Dates

First Submitted

August 5, 2022

First Submitted That Met QC Criteria

August 9, 2022

First Posted (Actual)

August 11, 2022

Study Record Updates

Last Update Posted (Estimated)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 12, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT22008TMV005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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