Mitral Regurgitation Clinical Trial
— APOLLO-EUOfficial title:
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | December 2038 |
Est. primary completion date | August 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen | |
France | CHU Bordeaux | Bordeaux | Pessac Cedex |
France | Henri-Mondor University Hospital | Créteil | |
France | CHU Timone | Marseille | |
France | Centre Cardiologique du Nord (CCN) | Saint-Denis | |
France | Clinique Pasteur | Toulouse | Cedex 03 |
France | CHRU de Tours | Tours | |
Germany | Heart and Diabetes Center NRW | Bad Oeynhausen | |
Germany | Deutsches Herzzentrum der Charité (DHZC) | Berlin | |
Germany | Universitätsklinikum Bonn | Bonn | |
Germany | Universitäres Herz- und Gefäßzentrum Hamburg | Hamburg | |
Germany | Herzzentrum Leipzig | Leipzig | |
Germany | University Medical Center Mainz | Mainz | |
Germany | Deutsches Herzzentrum München | München | |
Germany | LMU Clinic of University Hospital München | München | |
Netherlands | St. Antonius Hospital | Nieuwegein | |
Netherlands | Erasmus University Medical Center | Rotterdam | |
Spain | Hospital Universitario Ramón y Cajal | Madrid | |
Spain | Central University Hospital of Asturias | Oviedo | |
Switzerland | Universitätsspital Bern | Bern | |
United Kingdom | University Hospitals Sussex NHS Foundation Trust | Brighton | |
United Kingdom | Leeds General Infirmary | Leeds | |
United Kingdom | Guys & St Thomas NHS Foundation Trust - St Thomas Hospital London | London | |
United Kingdom | Royal Brompton Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Medtronic Cardiovascular |
Denmark, France, Germany, Netherlands, Spain, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety: all-cause mortality at 1-year post-procedure. | Rate of all-cause mortality at 1-year post-procedure. | 1 year | |
Primary | Efficacy: Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure. | 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 | Rate of all-cause mortality (Safety). | Rate of all-cause mortality at 30 days post-procedure. | 30 days | |
Secondary | Disabling stroke (Safety). | Rate of disabling stroke at 30 days post-procedure. | 30 days | |
Secondary | Acute Kidney Injury (stage 3 or with renal replacement) (Safety). | Rate of acute kidney injury (stage 3 or with renal replacement) at 30 days post-procedure. | 30 days | |
Secondary | Reoperation or reintervention (Safety). | Rate of reoperation or reintervention at 30 days post-procedure. | 30 days | |
Secondary | Major access site vascular complications (Safety). | Number of major access site vascular complications at 30 days post-procedure. | 30 days | |
Secondary | Mitral valve regurgitation (Efficacy). | Degree of mitral valve regurgitation at 1 year as assessed by the Echocardiography Core Laboratory. | 1 year | |
Secondary | NYHA functional class (Efficacy). | Change in NYHA functional class at 1 year (Efficacy). | 1 year | |
Secondary | Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) (Efficacy). | 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 | |
Secondary | Cardiovascular hospitalizations (Efficacy). | Cardiovascular hospitalizations through 1 year (Efficacy). | 1 year |
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