Mitral InsufficiencyNCT05625607
Polish Transcatheter Transfemoral Mitral Valve-in-Valve Implantation (Mitral ViV) Registry
An observational study of Mitral Insufficiency and Mitral Stenosis, run by Medical University of Warsaw at 7 sites in Poland.
Trial summary
In recent years increasing number of mitral bioprosthesis implantation, especially in elderly population, is observed. Bioprosthetic valves are associated with a lower risk of thrombotic and bleeding adverse events compared with mechanical prostheses, but their use is limited due to their durability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Insufficiency, Mitral Stenosis, Mitral Stenosis With Insufficiency
- What is being tested?
- Transcatheter mitral valve-in-valve implantation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 7 sitesPoland
- Study dates
- 17 Oct 2022to 31 May 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Polish patients with failed surgically implanted mitral bioprosthetic valves, qualified by decision of the Heart Team to TMVR. All patients meeting inclusion criteria will prospectively included in the study. Patients meeting inclusion criteria before the set-up of registry will be included retrospectively.
Who may be able to join
- Failing surgically implanted mitral bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
- Qualification for TMVR by decision of the local Heart Team
- Patient provided written informed consent
Who cannot join
- Disqualification from TMVR
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Poland7 sites, 7 recruiting
- Recruiting
Medical University of Białystok
Bialystok, 15-089
Paweł Kralisz, MD, PhD, +48 85 746 84 96, kki@umb.edu.pl
- Recruiting
Medical University of Gdańsk
Gdansk, 80-210
Dariusz Jagielak, MD, PhD, +48 58 584 42 00, kardchir@gumed.edu.pl
- Recruiting
Medical University of Silesia
Katowice, 40-055
Wojciech Wojakowski, MD,PhD, +48 32 359 86 90, kk3@gcm.pl
- Recruiting
Medical University of Łódź
Lodz, 90-419
Andrzej Walczak, MD, PhD, +48 42 201 44 60, poczta@csk.umed.pl
- Recruiting
Medical University of Opole
Opole, 45-052
Jerzy Sacha, MD, PhD, +48 77 45 20 660, kardiologia@usk.opole.pl
- Recruiting
Medical University of Warsaw
Warsaw, 02-091
Maciej Mazurek, MD, +48 510265843, maciej.j.mazurek@gmail.com
Zenon Huczek, MD, PhD
- Recruiting
Institute of Cardiology
Warsaw, 04-628
Adam Witkowski, MD, PhD, +48 22 343 43 42, kchw@ikard.pl
Marcin Demkow, MD, PhD
About this study
Official title: Evaluation of Clinical Outcomes of Transcatheter Transfemoral Mitral Valve-in-Valve Implantation in Polish Population- Observational Multicenter Registry
In recent years increasing number of mitral bioprosthesis implantation, especially in elderly population, is observed. Bioprosthetic valves are associated with a lower risk of thrombotic and bleeding adverse events compared with mechanical prostheses, but their use is limited due to their durability. After years numerous patients may develop bioprosthesis failure, requiring valve reintervention. Significantly burdened ones are oftentimes disqualified or not referred to surgery redo. An emerging treatment method for these patients is transcatheter mitral valve-in-valve implantation as an alternative to re-operation. This technique is applied with the use of devices previously dedicated to transcatheter aortic valve implantation (TAVI). Recent papers prove that transcatheter mitral valve replacement (TMVR) is a safe and effective procedure when performed in a selected group of high-surgical-risk patients. However, data regarding the Polish population are limited. Therefore, the aim of the study is to create a nationwide registry, collecting data from all Polish centers performing TMVR in order to describe the population of patients developing mitral bioprosthesis failure, evaluate their follow-up after TMVR as well as results of the transcatheter valvular intervention and identify potential limitations of the procedure.
- Conditions
- Mitral Insufficiency, Mitral Stenosis, Mitral Stenosis With Insufficiency, Heart Failure, Bioprosthesis Failure
- Being tested
- Transcatheter mitral valve-in-valve implantation
- Keywords
- Transcatheter mitral valve replacement, Transcatheter mitral valve implantation, Mitral valve-in-valve, Mitral valve insufficiency, Mitral stenosis, Mitral regurgitation, Bioprosthesis failure, Left ventricle outflow tract obstruction
- Medical subject headings
- Mitral Valve Insufficiency, Mitral Valve Stenosis, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter mitral valve-in-valve implantationProcedure or surgery
Transcatheter transfemoral mitral valve-in-valve implantation is an alternative for surgery redo in high-surgical-risk patients with bioprosthetic valve failure. The procedure is performed via femoral vein access. By the transseptal puncture (in the postero-inferior part of the interatrial septum) and balloon septostomy, the bioprosthetic valve is introduced through the degenerative valve into the left ventricle. The valve is expanded in the mitral position during rapid ventricle pacing.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of all-cause mortality
Endpoint described as n=x (y%).
Measured: 1 year
Rate of hospitalization
Hospitalization for valve-related symptoms or worsening congestive heart failure.
Endpoint described as n=x (y%).
Measured: 1 year
Rate of neurological events
All stroke, transient ischemic attack (TIA). Endpoint described as n=x (y%).
Measured: 1 year
Rate of myocardial infarction
Endpoint described as n=x (y%).
Measured: 1 year
Rate of valve-related dysfunction
Mean transvalvular gradient ≥5mmHg; ≥mitral regurgitation; ≥mild paravalvular leak; left ventricle outflow tract obstruction (LVOTO)- (acute hemodynamic deterioration associated with imaging evidence of LVOTO; mean LVOT pressure gradient increasement ≥10 mmHg compared to the baseline value).
Endpoint described as n=x (y%).
Measured: 1 year
Secondary outcomes (4)
Rate of technical success
Absence of procedural mortality; successful access, delivery, and retrieval of the device delivery system; successful deployment and correct positioning of the first intended device; freedom from emergency surgery or reintervention related to the device or access procedure.
Endpoint described as n=x (y%).
Measured: at 24 hours
Rate of device success
Absence of procedural mortality or stroke; proper placement and positioning of the device; freedom from unplanned surgical or interventional procedures related to the device or access procedure; continued intended safety and performance of the device.
Endpoint described as n=x (y%).
Measured: 30 days, 6 month, 1 year
Rate of procedural success
Device success (either optimal or acceptable), and absence of major device or procedure related serious adverse events, including:
- Death B. Stroke C. Life-threatening bleeding (Mitral Valve Academic Research Consortium scale) D. Major vascular complications E. Major cardiac structural complications F. Stage 2 or 3 acute kidney injury (includes new dialysis) G. Myocardial infarction or coronary ischaemia requiring PCI or CABG H. Severe hypotension, heart failure, or respiratory failure requiring intravenous pressors 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.
- Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention Endpoint described as n=x (y%).
Measured: 30 days
Rate of patient success
- Device success; II. Patient returned to the pre-procedural setting; III. No rehospitalizations or reinterventions for the underlying condition; IV. Improvement from baseline in symptoms; improvement by ≥1 functional class in New York Heart Association scale. Nominal values from I to IV, where higher value indicates worse outcome; V. Improvement from baseline in functional status; improvement by ≥50 m in 6-min walk test. Continuous values in meters, where higher value indicates better outcome; VI. Improvement from baseline in quality-of-life; improvement by ≥10 in Kansas City Cardiomyopathy Questionnaire. Scores are scaled from 0 to 100, where higher value indicates better outcome.
Endpoint described as n=x (y%).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start17 Oct 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral InsufficiencyStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Cardiology, Warsaw, Poland, Medical University of Bialystok, University of Opole, Medical University of Gdansk, Medical University of Silesia, Medical University of Lodz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625607
- Sponsor's protocol ID
- WUM-MViV
- Status last verified
- Nov 2022
- First submitted
- 2 Nov 2022
- Last updated
- 23 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Stone GW, Adams DH, Abraham WT, Kappetein AP, Genereux P, Vranckx P, Mehran R, Kuck KH, Leon MB, Piazza N, Head SJ, Filippatos G, Vahanian AS; Mitral Valve Academic Research Consortium (MVARC). Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 2: endpoint definitions: A consensus document from the Mitral Valve Academic Research Consortium. Eur Heart J. 2015 Aug 1;36(29):1878-91. doi: 10.1093/eurheartj/ehv333. Epub 2015 Jul 13.
PubMed 26170468
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Outcomes of Transcatheter Transfemoral Mitral Valve-in-Valve Implantation in Polish Population- Observational Multicenter Registry
- ClinicalTrials.gov ID
- NCT05625607
- Acronym / sponsor ID
- WUM-MViV
- Conditions
- Mitral Insufficiency, Mitral Stenosis, Mitral Stenosis With Insufficiency, Heart Failure, Bioprosthesis Failure
- Keywords
- Transcatheter mitral valve replacement, Transcatheter mitral valve implantation, Mitral valve-in-valve, Mitral valve insufficiency, Mitral stenosis, Mitral regurgitation, Bioprosthesis failure, Left ventricle outflow tract obstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- National Institute of Cardiology, Warsaw, Poland, Medical University of Bialystok, University of Opole, Medical University of Gdansk, Medical University of Silesia, Medical University of Lodz
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 23 Nov 2022 (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.
In recent years increasing number of mitral bioprosthesis implantation, especially in elderly population, is observed. Bioprosthetic valves are associated with a lower risk of thrombotic and bleeding adverse events compared with mechanical prostheses, but their use is limited due to their durability. After years numerous patients may develop bioprosthesis failure, requiring valve reintervention. Significantly burdened ones are oftentimes disqualified or not referred to surgery redo. An emerging treatment method for these patients is transcatheter mitral valve-in-valve implantation as an alternative to re-operation. This technique is applied with the use of devices previously dedicated to transcatheter aortic valve implantation (TAVI). Recent papers prove that transcatheter mitral valve replacement (TMVR) is a safe and effective procedure when performed in a selected group of high-surgical-risk patients. However, data regarding the Polish population are limited. Therefore, the aim of the study is to create a nationwide registry, collecting data from all Polish centers performing TMVR in order to describe the population of patients developing mitral bioprosthesis failure, evaluate their follow-up after TMVR as well as results of the transcatheter valvular intervention and identify potential limitations of the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Polish patients with failed surgically implanted mitral bioprosthetic valves, qualified by decision of the Heart Team to TMVR. All patients meeting inclusion criteria will prospectively included in the study. Patients meeting inclusion criteria before the set-up of registry will be included retrospectively.
Key inclusion criteria (3 listed)
- Failing surgically implanted mitral bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
- Qualification for TMVR by decision of the local Heart Team
- Patient provided written informed consent
Key exclusion criteria (1 listed)
- Disqualification from TMVR
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 |
|---|---|---|
| Transcatheter mitral valve-in-valve implantationTranscatheter transfemoral mitral valve-in-valve implantation is an alternative for surgery redo in high-surgical-risk patients with bioprosthetic valve failure. The procedure is performed via femoral vein access. By the transseptal puncture (in the postero-inferior part of the interatrial septum) and balloon septostomy, the bioprosthetic valve is introduced through the degenerative valve into the left ventricle. The valve is expanded in the mitral position during rapid ventricle pacing. | Procedure or surgery | – |
Primary outcome
Rate of all-cause mortality
Time frame: 1 year
Endpoint described as n=x (y%).
Rate of hospitalization
Time frame: 1 year
Hospitalization for valve-related symptoms or worsening congestive heart failure. Endpoint described as n=x (y%).
Rate of neurological events
Time frame: 1 year
All stroke, transient ischemic attack (TIA). Endpoint described as n=x (y%).
Rate of myocardial infarction
Time frame: 1 year
Endpoint described as n=x (y%).
Rate of valve-related dysfunction
Time frame: 1 year
Mean transvalvular gradient ≥5mmHg; ≥mitral regurgitation; ≥mild paravalvular leak; left ventricle outflow tract obstruction (LVOTO)- (acute hemodynamic deterioration associated with imaging evidence of LVOTO; mean LVOT pressure gradient increasement ≥10 mmHg compared to the baseline value). Endpoint described as n=x (y%).
4 secondary outcomes
Rate of technical success
Time frame: at 24 hours
Rate of device success
Time frame: 30 days, 6 month, 1 year
Rate of procedural success
Time frame: 30 days
Rate of patient success
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Background: PubMed 26170468Stone GW, Adams DH, Abraham WT, Kappetein AP, Genereux P, Vranckx P, Mehran R, Kuck KH, Leon MB, Piazza N, Head SJ, Filippatos G, Vahanian AS; Mitral Valve Academic Research Consortium (MVARC). Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 2: endpoint definitions: A consensus document from the Mitral Valve Academic Research Consortium. Eur Heart J. 2015 Aug 1;36(29):1878-91. doi: 10.1093/eurheartj/ehv333. Epub 2015 Jul 13.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Insufficiency and Mitral Stenosis, run by Medical University of Warsaw at 7 sites in Poland.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of all-cause mortality (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05625607, which also lists 1 linked publication.
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 23 Nov 2022.