Mitral RegurgitationMUSENCT05871983
Munich Transcatheter Mitral Valve Safety and Effectiveness
A study testing MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM in people with Mitral Regurgitation and Mitral Valve Disease, run by P+F Products + Features GmbH at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mitral Regurgitation, Mitral Valve Disease
- What is being tested?
- MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 30 Jul 2023to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Show all 40Show fewer
- 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
Trial locations and contacts
10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 3 countries
Argentina4 sites
Fundación Favaloro
Buenos Aires, C1093
Oscar Mendiz, MD, omendiz@ffavaloro.org
Oscar Mendiz, MD
Hospital Italiano De Buenos Aires
Buenos Aires, C1199ABB
Carla Agatiello, MD, carla.agatiello@hospitalitaliano.org.ar
Carla Agatiello, MD
Hospital César Milstein
Buenos Aires, C1221
Miguel Payaslian, MD, mopian@yahoo.com.ar
Miguel Payaslian, MD
Hospital Fernandez/Sanatorio Milstein
Buenos Aires, C1425AGP
Miguel Payaslian, MD, mopian@yahoo.com.ar
Miguel Payaslian, MD
Brazil3 sites
Instituto Estadual De Cardiologia Aloysio De Castro
Rio de Janeiro, 22261-010
Marcio Jose Montenegro Da Costa, MD, marciojmontenegro@gmail.com
Marcio Jose Montenegro Da Costa, MD
Instituto Dante Pazzanese De Cardiologia
São Paulo, 04012-909
Dimytri Siqueira, MD, dimytrisiqueira@gmail.com
Dimytri Siqueira, MD
Instituto Do Coração (InCor) De São Paulo
São Paulo, 05403-900
Alexandre Abizaid, MD, aabizaid@uol.com.br
Alexandre Abizaid
Chile3 sites
Hospital Del Torax De Santiago
Santiago, 7500691
Christian Dauvergne, MD, cdauvergnem@yahoo.com
Christian Dauvergne, MD
Hospital Dr Sotero Del Rio De Santiago
Santiago, 8150215
Martín Valdebenito, MD, mvaldet@gmail.com
Martín Valdebenito, MD
Hospital Las Higueras - Talcahuano
Talcahuano, 4270940
Osvaldo Perez, MD, osperez2000@gmail.com
Osvaldo Perez, MD
About this study
Official title: Clinical Evaluation of Safety and Effectiveness of the Munich Transcatheter Mitral Valve Replacement (TMVR) System
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.
Read the 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.
- Conditions
- Mitral Regurgitation, Mitral Valve Disease
- Being tested
- MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM
- Keywords
- mitral regurgitation, heart failure
- Medical subject headings
- Mitral Valve Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
Secondary Safety Endpoints
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
Measured: 90-day, 180-day, 1 year and annually at year 2, 3, 4 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start30 Jul 2023 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- P+F Products + Features GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meditrial USA Inc.
- Responsible party
- Sponsor
- Investigators
- Katharina Kiss, MD, Study chair, CEO, Products & Features
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871983
- Sponsor's protocol ID
- CTP-MIT-001
- Acronym
- MUSE
- Status last verified
- Jul 2023
- First submitted
- 11 Apr 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Safety and Effectiveness of the Munich Transcatheter Mitral Valve Replacement (TMVR) System
- ClinicalTrials.gov ID
- NCT05871983
- Acronym / sponsor ID
- MUSE / CTP-MIT-001
- Conditions
- Mitral Regurgitation, Mitral Valve Disease
- Keywords
- mitral regurgitation, heart failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- P+F Products + Features GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Meditrial USA Inc.
- Study start
- 30 Jul 2023 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single-Arm | Experimental | Device: MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEMThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- Moderate or severe mitral regurgitation (> 3+)
- 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
Key exclusion criteria (40 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEMThe 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. | Device | Single-Arm |
Primary outcome
Primary Safety Endpoints
Time frame: 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.
1 secondary outcome
Secondary Safety Endpoints
Time frame: 90-day, 180-day, 1 year and annually at year 2, 3, 4 and 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Products \& Features, manufacturer of MUNICH Transcatheter Mitral Valve SystemLink provided by the sponsor.
- Meditrial Clinical Research OrganizationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katharina Kiss, MD study chair
CEO, Products & Features
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM in people with Mitral Regurgitation and Mitral Valve Disease, run by P+F Products + Features GmbH at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Argentina, Brazil, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica E Tocchi, MPH, PhD (9176841700, m.tocchi@meditrial.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoints (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.