Munich Transcatheter Mitral Valve Safety and Effectiveness

NCT05871983 | Not Yet Recruiting DMC

• 1 other identifier: CTP-MIT-001
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 10

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.

Conditions

Mitral Regurgitation; Mitral Valve Disease

Keywords

mitral regurgitation; heart failure

Outcome Measures

Primary Outcomes (1)

• Primary Safety Endpoints

  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.

  30 days

Secondary Outcomes (1)

• Secondary Safety Endpoints

  90-day, 180-day, 1 year and annually at year 2, 3, 4 and 5

Other Outcomes (6)

• Secondary Performance Assessment

  Intraprocedural

• Secondary Effectiveness Assessment: Reduction of mitral regurgitation

  30-day, 90-day, 180-day, 1-year and annually at year 2, 3, 4,5

• Secondary Effectiveness Assessment: Changes in Ejection Fraction

  30-day, 90-day, 180-day, 1-year and annually at year 2, 3, 4,5

Study Arms (1)

Single-Arm

EXPERIMENTAL

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

Interventions

MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM 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.

Single-Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• P+F Products + Features GmbH: lead
• Meditrial USA Inc.: collaborator

Study Sites (10)

Fundación Favaloro

Buenos Aires, C1093, Argentina

Location

Hospital Italiano De Buenos Aires

Buenos Aires, C1199ABB, Argentina

Location

Hospital César Milstein

Buenos Aires, C1221, Argentina

Location

Hospital Fernandez/Sanatorio Milstein

Buenos Aires, C1425AGP, Argentina

Location

Instituto Estadual De Cardiologia Aloysio De Castro

Rio de Janeiro, 22261-010, Brazil

Location

Instituto Dante Pazzanese De Cardiologia

São Paulo, 04012-909, Brazil

Location

Instituto Do Coração (InCor) De São Paulo

São Paulo, 05403-900, Brazil

Location

Hospital Del Torax De Santiago

Santiago, 7500691, Chile

Location

Hospital Dr Sotero Del Rio De Santiago

Santiago, 8150215, Chile

Location

Hospital Las Higueras - Talcahuano

Talcahuano, 4270940, Chile

Location

Related Links

• Products \& Features, manufacturer of MUNICH Transcatheter Mitral Valve System
• Meditrial Clinical Research Organization

MeSH Terms

Conditions

Mitral Valve Insufficiency; Heart Failure

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Katharina Kiss, MD

  CEO, Products & Features

  STUDY CHAIR

Central Study Contacts

Monica E Tocchi, MPH, PhD

CONTACT

9176841700; m.tocchi@meditrial.net

Monica Tocchi, MD

CONTACT

9176841700; M.Tocchi@meditrial.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 23, 2023
• Study Start: July 30, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2029
• Last Updated: July 11, 2023

Record last verified: 2023-07

Locations

AR (4); BR (3); CL (3)