Degeneration Mitral BioprosthesisDURABLE-MitralNCT07151989
Influence of Original Native Mitral Valve Lesion (Stenosis or Steno-insufficiency vs. Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Mitral Valve Replacement
An observational study of Degeneration Mitral Bioprosthesis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
It aims to perform a retrospective, multi-center, observational study. All patients undergoing elective mitral valve replacement from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated section) will be enrolled in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degeneration Mitral Bioprosthesis
- What is being tested?
- Mitral valve replacement
- Type of treatment
- Surgery or procedure
- How many people
- 3,500 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2024to 1 May 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing elective mitral valve replacement from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated section) will be enrolled in the study. These patients will be followed-up as part of routine care, and information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and postoperative 4 echocardiography will be available for analysis. Once consent is given, and if required by local governance, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.
Who may be able to join
- Age ≥ 18 years;
- Patients who underwent isolated mitral valve replacement for stenosis or regurgitation
- Signed informed consent, inclusive of release of medical information where required by local governance.
Who cannot join
- - Aortic and mitral valve replacement associated with surgery of ascending aorta/aortic root;
- Aortic and mitral valve replacement associated with other cardiac valve surgery (apart from arrythmia-related ablation or procedures);
- Previous cardiac surgery of any kind;
- Surgery for acute endocarditis
- Surgery for Type A aortic dissection
- Participation in another clinical trial that could interfere with the endpoints of this study.
- Pregnant or breastfeeding at time of screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
It aims to perform a retrospective, multi-center, observational study. All patients undergoing elective mitral valve replacement from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated section) will be enrolled in the study. These patients will be followed-up as part of routine care, and information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and postoperative echocardiography will be available for analysis. Once consent is given, and if required by local governance, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.
Read the detailed description
It aims to perform a retrospective, multi-center, observational study. All patients undergoing elective mitral valve replacement from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated section) will be enrolled in the study. These patients will be followed-up as part of routine care, and information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and postoperative echocardiography will be available for analysis. Once consent is given, and if required by local governance, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.
- Conditions
- Degeneration Mitral Bioprosthesis
- Being tested
- Mitral valve replacement
- Keywords
- Mitral bioprosthesis degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral valve replacementProcedure or surgery
All operations were performed through median longitudinal sternotomy or mini-sternotomy.
Intraoperative transesophageal echocardiography (TOE) was used in all patients. Arterial cannulation was central and venous cannulation was achieved with a common two-stage cannula in the right atrium. Left ventricle was vented through the right superior pulmonary vein. In minimally invasive procedures, venous cannulation was achieved percutaneously. Myocardial protection was achieved by administration of cold crystalloid or blood cardioplegia at the surgeon's discretion in an antegrade (indirect or selective) or retrograde fashion. The removal of the calcified cusps and the decalcification of the annulus was performed according to traditional techniques. All the prosthesis were be implanted with supranular technique and 2-0 U-shaped pledgeted sutures.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with mitral bioprosthesis replacement | All patients undergoing elective mitral valve replacement from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated section) will be enrolled in the study. These patients will be followed-up as part of routine care, and information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and postoperative echocardiography will be available for analysis. Once consent is given, and if required by local governance, pre-, intra- and post-operative data will be collected in a dedicated, structured, database. Receives: Procedure: Mitral valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthesis degeneration due to physiological deterioration
Echocardiographic paramters will be used.
Quantitative and qualitative measurments swill be implied. The measurment used are listed below:
- Morphological Assessment (2D / 3D TTE \& TEE) Leaflet morphology: thickness, mobility, calcification, pannus, tears, perforations. Bioprosthetic ring/annulus: dehiscence, rocking motion, paravalvular defects. Presence of thrombus, pannus, or vegetation. Structural valve deterioration (SVD) features: leaflet thickening, restricted opening, abnormal motion.
- Hemodynamic Assessment (Doppler Echocardiography)
Mitral inflow pattern (continuous-wave Doppler across prosthesis):
Peak velocity (m/s)
Mean transprosthetic gradient (mmHg) - heart-rate dependent
Pressure half-time (PHT, ms) - limited use in prosthetic valves, but can suggest stenosis
Effective orifice area (EOA) (via continuity equation or PHT-derived, cautiously interpreted).
Doppler Velocity Index (DVI) = LVOT VTI / Prosthetic MV VTI (helps detect obstruction independent of fl
Measured: 20 years
Secondary outcomes (1)
Long term survival
How long is the survival after the operation
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Jan 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degeneration Mitral BioprosthesisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Other
- Enrolment
- 3,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Lorusso, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151989
- Sponsor's protocol ID
- METC 2023-0324-A-1
- Acronym
- DURABLE-Mitral
- Status last verified
- Aug 2025
- First submitted
- 7 Mar 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Original Native Mitral Valve Lesion (Stenosis or Steno-insufficiency vs. Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Mitral Valve Replacement
- ClinicalTrials.gov ID
- NCT07151989
- Acronym / sponsor ID
- DURABLE-Mitral / METC 2023-0324-A-1
- Conditions
- Degeneration Mitral Bioprosthesis
- Keywords
- Mitral bioprosthesis degeneration
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 3 Sep 2025 (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.
It aims to perform a retrospective, multi-center, observational study. All patients undergoing elective mitral valve replacement from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated section) will be enrolled in the study. These patients will be followed-up as part of routine care, and information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and postoperative echocardiography will be available for analysis. Once consent is given, and if required by local governance, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.
Detailed description
It aims to perform a retrospective, multi-center, observational study. All patients undergoing elective mitral valve replacement from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated section) will be enrolled in the study. These patients will be followed-up as part of routine care, and information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and postoperative echocardiography will be available for analysis. Once consent is given, and if required by local governance, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with mitral bioprosthesis replacement | – | Procedure: Mitral valve replacementAll patients undergoing elective mitral valve replacement from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated section) will be enrolled in the study. These patients will be followed-up as part of routine care, and information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and postoperative echocardiography will be available for analysis. Once consent is given, and if required by local governance, pre-, intra- and post-operative data will be collected in a dedicated, structured, database. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing elective mitral valve replacement from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated section) will be enrolled in the study. These patients will be followed-up as part of routine care, and information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and postoperative 4 echocardiography will be available for analysis. Once consent is given, and if required by local governance, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Patients who underwent isolated mitral valve replacement for stenosis or regurgitation
- Signed informed consent, inclusive of release of medical information where required by local governance.
Key exclusion criteria (7 listed)
- - Aortic and mitral valve replacement associated with surgery of ascending aorta/aortic root;
- Aortic and mitral valve replacement associated with other cardiac valve surgery (apart from arrythmia-related ablation or procedures);
- Previous cardiac surgery of any kind;
- Surgery for acute endocarditis
- Surgery for Type A aortic dissection
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 |
|---|---|---|
| Mitral valve replacementAll operations were performed through median longitudinal sternotomy or mini-sternotomy. Intraoperative transesophageal echocardiography (TOE) was used in all patients. Arterial cannulation was central and venous cannulation was achieved with a common two-stage cannula in the right atrium. Left ventricle was vented through the right superior pulmonary vein. In minimally invasive procedures, venous cannulation was achieved percutaneously. Myocardial protection was achieved by administration of cold crystalloid or blood cardioplegia at the surgeon's discretion in an antegrade (indirect or selective) or retrograde fashion. The removal of the calcified cusps and the decalcification of the annulus was performed according to traditional techniques. All the prosthesis were be implanted with supranular technique and 2-0 U-shaped pledgeted sutures. | Procedure or surgery | Patients treated with mitral bioprosthesis replacement |
Primary outcome
Prosthesis degeneration due to physiological deterioration
Time frame: 20 years
Echocardiographic paramters will be used. Quantitative and qualitative measurments swill be implied. The measurment used are listed below: 1. Morphological Assessment (2D / 3D TTE \& TEE) Leaflet morphology: thickness, mobility, calcification, pannus, tears, perforations. Bioprosthetic ring/annulus: dehiscence, rocking motion, paravalvular defects. Presence of thrombus, pannus, or vegetation. Structural valve deterioration (SVD) features: leaflet thickening, restricted opening, abnormal motion. 2. Hemodynamic Assessment (Doppler Echocardiography) Mitral inflow pattern (continuous-wave Doppler across prosthesis): Peak velocity (m/s) Mean transprosthetic gradient (mmHg) - heart-rate dependent Pressure half-time (PHT, ms) - limited use in prosthetic valves, but can suggest stenosis Effective orifice area (EOA) (via continuity equation or PHT-derived, cautiously interpreted). Doppler Velocity Index (DVI) = LVOT VTI / Prosthetic MV VTI (helps detect obstruction independent of fl
1 secondary outcome
Long term survival
Time frame: 20 years
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 3 Sep 2025.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degeneration Mitral Bioprosthesis, run by Maastricht University Medical Center at 1 site in Netherlands.
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 7 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: enrolling by invitation, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthesis degeneration due to physiological deterioration (time frame: 20 years). 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 3 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.