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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05496998
Other study ID # MDT22008TMV005
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 7, 2023
Est. completion date December 2038

Study information

Verified date May 2024
Source Medtronic Cardiovascular
Contact Hanne Gonnissen, PhD
Phone +31 (0)43 356 6566
Email rs.apolloeurope@medtronic.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Medtronic Cardiovascular

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

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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