Mitral Regurgitation
Conditions
Keywords
mitral, valve, regurgitation, TMVR, Intrepid™, symptomatic, severe
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
Interventions
DEVICEMedtronic 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
Sponsors
Medtronic Cardiovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: all-cause mortality at 1-year post-procedure. | 1 year | Rate of all-cause mortality at 1-year post-procedure. |
| Efficacy: Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure. | 30 days | Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure as assessed by the Echocardiography Core Laboratory. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of all-cause mortality (Safety). | 30 days | Rate of all-cause mortality at 30 days post-procedure. |
| Disabling stroke (Safety). | 30 days | Rate of disabling stroke at 30 days post-procedure. |
| Acute Kidney Injury (stage 3 or with renal replacement) (Safety). | 30 days | Rate of acute kidney injury (stage 3 or with renal replacement) at 30 days post-procedure. |
| Reoperation or reintervention (Safety). | 30 days | Rate of reoperation or reintervention at 30 days post-procedure. |
| Major access site vascular complications (Safety). | 30 days | Number of major access site vascular complications at 30 days post-procedure. |
| Mitral valve regurgitation (Efficacy). | 1 year | Degree of mitral valve regurgitation at 1 year as assessed by the Echocardiography Core Laboratory. |
| NYHA functional class (Efficacy). | 1 year | Change in NYHA functional class at 1 year (Efficacy). |
| Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) (Efficacy). | 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. |
| Cardiovascular hospitalizations (Efficacy). | 1 year | Cardiovascular hospitalizations through 1 year (Efficacy). |
Countries
Denmark, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom
Contacts
CONTACTHanne Gonnissen, PhD
PRINCIPAL_INVESTIGATORThomas Modine, Prof.
University Hospital, Bordeaux
PRINCIPAL_INVESTIGATORvon Bardeleben, Prof.
University Medical Center Mainz
Outcome results
None listed