Munich Transcatheter Mitral Valve Safety and Effectiveness

Not Applicable

Not yet recruiting

• Conditions: Mitral Valve Disease; Mitral Regurgitation
• Interventions: Device: MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM

• Registration Number: NCT05871983
• Lead Sponsor: P+F Products + Features GmbH

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.

Study Timeline

• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-05-23
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-07
• Last Update Posted: 2023-07-11
• Study Start: 2023-07-30
• Primary Completion: 2025-12-30
• Study Completion: 2029-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-Arm	MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM	This is a prospective, non-randomized, single-arm, international, multicenter, clinical study designed to evaluate the safety, efficacy, and performance of the P\&F MUNICH TMVR System in a population of patients with moderate to severe symptomatic Mitral Regurgitation.

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoints	30 days	The primary safety endpoint is to evaluate a 30-day major adverse events (MAE) rate, where MAE is a composite of the following device- or procedure-related events: * All-cause mortality; * Stroke; * Life-threatening bleeding (MVARC scale); * Major vascular complications; * Major cardiac structural complications; * Myocardial infarction or coronary ischemia requiring PCI or CABG; * Stage 2 or 3 acute kidney injury (includes new dialysis); * Severe hypotension, worsening of heart failure, or respiratory failure requiring intravenous pressor or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for \>48 h.; * Emergency surgery or re-intervention.

Secondary Outcome Measures

Name	Time	Method
Secondary Safety Endpoints	90-day, 180-day, 1 year and annually at year 2, 3, 4 and 5	Secondary safety endpoints include an evaluation at 90-day, 180-day, 1 year and annually at year 2, 3, 4 and 5 (inclusive of unscheduled visits): * Death, cardiac, non-cardiac; * Stroke; * Myocardial Infarction; * Any device related complication/ dysfunction; * New atrial fibrillation (AF); * New conduction disturbance requiring permanent pacemaker (PM); * Major access and vascular complications; * Stage 2 or 3 acute kidney injury (includes dialysis); * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention

Trial Locations

Locations (10)

Fundación Favaloro; 🇦🇷 Buenos Aires, Argentina

Hospital Dr Sotero Del Rio De Santiago; 🇨🇱 Santiago, Chile

Hospital Las Higueras - Talcahuano; 🇨🇱 Talcahuano, Chile

Hospital César Milstein; 🇦🇷 Buenos Aires, Argentina

Instituto Estadual De Cardiologia Aloysio De Castro; 🇧🇷 Rio de Janeiro, Brazil

Hospital Fernandez/Sanatorio Milstein; 🇦🇷 Buenos Aires, Argentina

Instituto Do Coração (InCor) De São Paulo; 🇧🇷 São Paulo, Brazil

Hospital Italiano De Buenos Aires; 🇦🇷 Buenos Aires, Argentina

Instituto Dante Pazzanese De Cardiologia; 🇧🇷 São Paulo, Brazil

Hospital Del Torax De Santiago; 🇨🇱 Santiago, Chile