Clinical trial NCT05871983: Munich Transcatheter Mitral Valve Safety and Effectiveness
Official title: Clinical Evaluation of Safety and Effectiveness of the Munich Transcatheter Mitral Valve Replacement (TMVR) System
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Mitral Valve Disease
Keywords: mitral regurgitation
heart failure
Lead sponsor: P+F Products + Features GmbH
Sponsor class: INDUSTRY
Collaborators: name: Meditrial USA Inc.
First posted: 2023-05-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, non-randomized, single-arm, international, multicenter, clinical study designed to evaluate the safety and performance of the P\&F MUNICH TMVR System in a population of patients with moderate to severe symptomatic mitral regurgitation, who are not suitable for surgical or approved percutaneous treatments. All patients will be followed closely up to 12 months after the intervention and long-term safety and effectiveness will be collected annually up to 5 years.
Primary purpose: TREATMENT

Brief summary: The Munich Trascatheter Mitral Valve System is intended for beating heart, mitral valve replacement in patients with a diseased, damaged, or malfunctioning mitral valve. Access is provided through the Femoral Vein and transseptal approach by means of a 27Fr catheter.

The bioprosthetic valve consists of a self-expanding, tri-leaflet, dry bovine-pericardial valve. The dry tissue allows the valve to be conveniently pre-loaded. The valve is available in three sizes and has been designed to reduce the complexity of implantation in comparison to other TMVR systems.

Detailed description: This is a prospective multicenter clinical investigation designed to evaluate the safety and effectiveness of the Munich TMVR System in a population of patients with moderate to severe, symptomatic mitral regurgitation, who are not suitable for surgical treatments.

Patients who meet all of the study inclusion criteria, will be treated with the Munich valve. After the intervention, patients will be followed up closely for 12 months. Long term safety and efficacy data will be collected annually up to 5 years.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Moderate or severe mitral regurgitation (\> 3+)

   1. For Degenerative MR: EROA ≥ 40 mm2 or regurgitant volume ≥ 60ml
   2. For Secondary MR: EROA \> 30 mm2 or regurgitant volume \> 45ml (i.e., MR moderate or severe by ASE criteria)
3. New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
4. Subject is under guideline directed medical therapy for at least one month
5. Subject is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and consideration of co-morbidities, frailty and disability
6. Subject meets the anatomical criteria for Munich TMVR System
7. Patient is willing to participate in the study and provides signed informed consent.

Exclusion Criteria:

General Conditions

1. Subject who is currently participating in an investigational study, other than this study
2. Subjects allergic to bovine tissue
3. Subjects with uncontrolled hypotension
4. Hemodynamic instability
5. Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated and has an allergy to Nitinol alloys
6. Intolerance to antiplatelet, anticoagulant or thrombolytic medications
7. Bleeding diathesis or hypercoagulable state
8. Active peptic ulcer or active gastrointestinal bleeding
9. Pulmonary artery systolic pressure \>70 mmHg
10. Renal insufficiency
11. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
12. Subject with hepatic insufficiency
13. Subject has a co-morbid illness that may result in a life expectancy of less than one year
14. Active infection that requires antibiotic therapy
15. Subject is pregnant, breastfeeding or intend to become pregnant within one year, and female subjects in childbearing age NOT using a highly effective method of contraception with a failure rate of less than 1% per year.

    Comorbidities
16. Prior stroke or TIA within 3 months or Modified Rankin Scale ≥4 disability
17. Acute myocardial infarction within the previous 30 day
18. Any prior heart valve surgery or transcatheter mitral intervention
19. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
20. Rheumatic heart disease or endocarditis within the previous 3 months
21. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis
22. Severe organic lesion with retracted chordae or congenital malformation and lack of valvular tissue
23. Any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.
24. Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)
25. Untreated clinically significant coronary artery disease requiring revascularization
26. Tricuspid valve disease requiring surgery or severe tricuspid regurgitation
27. Aortic or pulmonic valve disease requiring surgery
28. CRT/ICD implant within 30 days
29. NYHA class IVb
30. UNOS stadium 1 heart transplantation or previous orthotopic heart transplantation

    Anatomical and Functional
31. Left Ventricular Ejection Fraction (LVEF) \<30%
32. LV end diastolic diameter \> 70mm
33. Significant abnormalities of the sub-valvular apparatus.
34. Severe mitral annular or leaflets calcification
35. Left atrial or LV thrombus or vegetation
36. Severe right ventricular dysfunction
37. Severe tricuspid or aortic valve disease

Primary outcomes:
measure: Primary Safety Endpoints
timeFrame: 30 days
Secondary outcomes:
measure: Secondary Safety Endpoints
timeFrame: 90-day, 180-day, 1 year and annually at year 2, 3, 4 and 5
Other outcomes:
measure: Secondary Performance Assessment
timeFrame: Intraprocedural
measure: Secondary Effectiveness Assessment: Reduction of mitral regurgitation
timeFrame: 30-day, 90-day, 180-day, 1-year and annually at year 2, 3, 4,5
measure: Secondary Effectiveness Assessment: Changes in Ejection Fraction
timeFrame: 30-day, 90-day, 180-day, 1-year and annually at year 2, 3, 4,5
measure: Secondary Effectiveness Assessment: NYHAC
timeFrame: 30-day, 90-day, 180-day, 1-year and annually at year 2, 3, 4,5
measure: Secondary Effectiveness Assessment: KCCQ
timeFrame: 30-day, 90-day, 180-day, 1-year and annually at year 2, 3, 4,5
measure: Secondary Effectiveness Assessment: Hospitalization Rate
timeFrame: 30-day, 90-day, 180-day, 1-year and annually at year 2, 3, 4,5
Locations:
city: Buenos Aires
country: Argentina
facility: Fundación Favaloro
city: Buenos Aires
country: Argentina
facility: Hospital Italiano De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital César Milstein
city: Buenos Aires
country: Argentina
facility: Hospital Fernandez/Sanatorio Milstein
city: Rio de Janeiro
country: Brazil
facility: Instituto Estadual De Cardiologia Aloysio De Castro
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese De Cardiologia
city: São Paulo
country: Brazil
facility: Instituto Do Coração (InCor) De São Paulo
city: Santiago
country: Chile
facility: Hospital Del Torax De Santiago
city: Santiago
country: Chile
facility: Hospital Dr Sotero Del Rio De Santiago
city: Talcahuano
country: Chile
facility: Hospital Las Higueras - Talcahuano
Study officials:
affiliation: CEO, Products & Features
name: Katharina Kiss, MD
role: STUDY_CHAIR
References: