Clinical trial NCT05496998: Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Official title: Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR Transfemoral System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Keywords: mitral
valve
regurgitation
TMVR
Intrepid™
symptomatic
severe
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2022-08-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects 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.
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Safety: all-cause mortality at 1-year post-procedure.
timeFrame: 1 year
measure: Efficacy: Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure.
timeFrame: 30 days
Secondary outcomes:
measure: Rate of all-cause mortality (Safety).
timeFrame: 30 days
measure: Disabling stroke (Safety).
timeFrame: 30 days
measure: Acute Kidney Injury (stage 3 or with renal replacement) (Safety).
timeFrame: 30 days
measure: Reoperation or reintervention (Safety).
timeFrame: 30 days
measure: Major access site vascular complications (Safety).
timeFrame: 30 days
measure: Mitral valve regurgitation (Efficacy).
timeFrame: 1 year
measure: NYHA functional class (Efficacy).
timeFrame: 1 year
measure: Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) (Efficacy).
timeFrame: 1 year
measure: Cardiovascular hospitalizations (Efficacy).
timeFrame: 1 year
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
city: Toulouse
country: France
facility: Clinique Pasteur
state: Cedex 03
city: Bordeaux
country: France
facility: CHU Bordeaux
state: Pessac Cedex
city: Créteil
country: France
facility: Henri-Mondor University Hospital
city: Marseille
country: France
facility: CHU Timone
city: Nantes
country: France
facility: CHU de Nantes
city: Rennes
country: France
facility: CHU Rennes - Pontchaillou Hospital
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord (CCN)
city: Tours
country: France
facility: CHRU de Tours
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Center NRW
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité (DHZC)
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Hamburg
country: Germany
facility: Universitäres Herz- und Gefäßzentrum Hamburg
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Mainz
country: Germany
facility: University Medical Center Mainz
city: München
country: Germany
facility: Deutsches Herzzentrum München
city: München
country: Germany
facility: LMU Clinic of University Hospital München
city: Bologna
country: Italy
facility: Azienda Ospedaliero - Universitaria di Bologna - Policlinico S.Orsola Malpighi
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Oviedo
country: Spain
facility: Central University Hospital of Asturias
city: Bern
country: Switzerland
facility: Universitätsspital Bern
city: Brighton
country: United Kingdom
facility: University Hospitals Sussex NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: London
country: United Kingdom
facility: Guys & St Thomas NHS Foundation Trust - St Thomas Hospital London
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Thomas Modine, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Mainz
name: von Bardeleben, Prof.
role: PRINCIPAL_INVESTIGATOR
References: