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NCT05871983 | Not yet recruiting | Mitral Regurgitation


Munich Transcatheter Mitral Valve Safety and Effectiveness
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.

Condition or disease

Mitral Regurgitation

Mitral Valve Disease

Intervention/treatment

MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 60 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Safety and Effectiveness of the Munich Transcatheter Mitral Valve Replacement (TMVR) System
Actual Study Start Date : July 30, 2023
Estimated Primary Completion Date : December 30, 2025
Estimated Study Completion Date : December 30, 2029
Arm Intervention/treatment

Experimental: 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.

Device: MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • Age ≥ 18 years
  • Moderate or severe mitral regurgitation (> 3+)
  • For Degenerative MR: EROA ≥ 40 mm2 or regurgitant volume ≥ 60ml
  • For Secondary MR: EROA > 30 mm2 or regurgitant volume > 45ml (i.e., MR moderate or severe by ASE criteria)
  • New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
  • Subject is under guideline directed medical therapy for at least one month
  • 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
  • Subject meets the anatomical criteria for Munich TMVR System
  • Patient is willing to participate in the study and provides signed informed consent.
Exclusion Criteria
  • General Conditions
  • Subject who is currently participating in an investigational study, other than this study
  • Subjects allergic to bovine tissue
  • Subjects with uncontrolled hypotension
  • Hemodynamic instability
  • Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated and has an allergy to Nitinol alloys
  • Intolerance to antiplatelet, anticoagulant or thrombolytic medications
  • Bleeding diathesis or hypercoagulable state
  • Active peptic ulcer or active gastrointestinal bleeding
  • Pulmonary artery systolic pressure >70 mmHg
  • Renal insufficiency
  • Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
  • Subject with hepatic insufficiency
  • Subject has a co-morbid illness that may result in a life expectancy of less than one year
  • Active infection that requires antibiotic therapy
  • 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
  • Prior stroke or TIA within 3 months or Modified Rankin Scale ≥4 disability
  • Acute myocardial infarction within the previous 30 day
  • Any prior heart valve surgery or transcatheter mitral intervention
  • Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
  • Rheumatic heart disease or endocarditis within the previous 3 months
  • Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis
  • Severe organic lesion with retracted chordae or congenital malformation and lack of valvular tissue
  • Any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.
  • Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Tricuspid valve disease requiring surgery or severe tricuspid regurgitation
  • Aortic or pulmonic valve disease requiring surgery
  • CRT/ICD implant within 30 days
  • NYHA class IVb
  • UNOS stadium 1 heart transplantation or previous orthotopic heart transplantation
  • Anatomical and Functional
  • Left Ventricular Ejection Fraction (LVEF) <30%
  • LV end diastolic diameter > 70mm
  • Significant abnormalities of the sub-valvular apparatus.
  • Severe mitral annular or leaflets calcification
  • Left atrial or LV thrombus or vegetation
  • Severe right ventricular dysfunction
  • Severe tricuspid or aortic valve disease

Munich Transcatheter Mitral Valve Safety and Effectiveness

Location Details


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Munich Transcatheter Mitral Valve Safety and Effectiveness

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Argentina,

Fundación Favaloro

Buenos Aires, Argentina, C1093

Not yet recruiting

Argentina,

Hospital Italiano De Buenos Aires

Buenos Aires, Argentina, C1199ABB

Not yet recruiting

Argentina,

Hospital César Milstein

Buenos Aires, Argentina, C1221

Not yet recruiting

Argentina,

Hospital Fernandez/Sanatorio Milstein

Buenos Aires, Argentina, C1425AGP

Not yet recruiting

Brazil,

Instituto Estadual De Cardiologia Aloysio De Castro

Rio de Janeiro, Brazil, 22261-010

Not yet recruiting

Brazil,

Instituto Dante Pazzanese De Cardiologia

São Paulo, Brazil, 04012-909

Not yet recruiting

Brazil,

Instituto Do Coração (InCor) De São Paulo

São Paulo, Brazil, 05403-900

Not yet recruiting

Chile,

Hospital Del Torax De Santiago

Santiago, Chile, 7500691

Not yet recruiting

Chile,

Hospital Dr Sotero Del Rio De Santiago

Santiago, Chile, 8150215

Not yet recruiting

Chile,

Hospital Las Higueras - Talcahuano

Talcahuano, Chile, 4270940

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