Munich Transcatheter Mitral Valve Safety and Effectiveness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-30

Study Completion Date

2029-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Caisson Transcatheter Mitral Valve Replacement (TMVR)

NCT03661398

Mitral Regurgitation Mitral Valve Disease Mitral Valve Failure +3 more

UNKNOWN NA

MitraClip® After Surgical Mitral Valve Repair

NCT02853955

Mitral Regurgitation

UNKNOWN

MitraClip for the Treatment of Moderate Functional Mitral Regurgitation: EVOLVE-MR

NCT03705312

Mitral Regurgitation Heart Failure Mitral Valve Regurgitation Due to Cardiomyopathy (Disorder)

UNKNOWN NA

Chordal Repair for Transcatheter Mitral Valve Repair (TMVr)

NCT04281940

Degenerative Mitral Valve Disease Mitral Valve Regurgitation

COMPLETED NA

To Evaluate the Efficacy and Safety of the Transfemoral Mitral Valve Repair System in the Treatment of Patients With Moderately Severe and Severe Functional Mitral Regurgitation(FMR) Who Remained Clinically Symptomatic After Guideline-directed Medical Treatment

NCT05508438

Mitral Valve Insufficiency

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mitral Regurgitation Mitral Valve Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single-Arm

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.

Group Type EXPERIMENTAL

MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM

Intervention Type DEVICE

The replacement valve consists of a self-expanding, tri-leaflet, dry bovine -pericardial valve. The dry tissue allows the valve to be conveniently pre-loaded. The key characteristics of Munich valve are:

* Nitinol stent frame
* Bovine pericardium
* Polyester skirt
* Anchoring system allows anchoring the frame to the annulus
* Hooks are used to reduce the mobility of the native leaflets and decrease risk of embolization.

The Munich TMVR system design proposed for this clinical investigation represents a significant evolution from previous TMVR designs:

* Transfemoral / transseptal access
* Self-expanding
* Dry pericardium (can be pre-loaded)
* No anchors
* 27 Fr delivery catheter (
* Sizes: 40/48/55mm
* Height 30 mm The valve is available in 3 sizes with a 30mm profile and has been designed to reduce the complexity of implantation in comparison to other TMVR systems.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM

The replacement valve consists of a self-expanding, tri-leaflet, dry bovine -pericardial valve. The dry tissue allows the valve to be conveniently pre-loaded. The key characteristics of Munich valve are:

* Nitinol stent frame
* Bovine pericardium
* Polyester skirt
* Anchoring system allows anchoring the frame to the annulus
* Hooks are used to reduce the mobility of the native leaflets and decrease risk of embolization.

The Munich TMVR system design proposed for this clinical investigation represents a significant evolution from previous TMVR designs:

* Transfemoral / transseptal access
* Self-expanding
* Dry pericardium (can be pre-loaded)
* No anchors
* 27 Fr delivery catheter (
* Sizes: 40/48/55mm
* Height 30 mm The valve is available in 3 sizes with a 30mm profile and has been designed to reduce the complexity of implantation in comparison to other TMVR systems.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes