Mitral RegurgitationNCT05733988
Edge-To-Edge Technique Used as a Bailout in Case of Sub-Optimal Mitral Repair: Very Long-Term Results
An observational study of Mitral Regurgitation, run by Michele De Bonis at 1 site in Italy.
Trial summary
The absence of residual mitral regurgitation (MR) after mitral valve repair is of paramount importance for the long term durability of the valve repair. Thus, ideally, after weaning from cardio-pulmonary by-pass (CPB) the trans-esophageal echocardiogram (TEE) should show no (or only trivial) residual MR, good… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- Bailout edge to edge
- Type of treatment
- Surgery or procedure
- How many people
- 81 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jul 2021to 31 Jul 2021
- 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 Any age
- Child, Adult, Older adult
Study population: Patients who underwent a mitral valve repair surgery and in whom, at the intraoperative echo control, results where not satisfying, so an edge-to-edge repair was also performed as a bailout procedure
Who may be able to join
- Adult patients;
- Patients underwent mitral valve repair, with more than mild residual MR at the intraoperative TEE after leaving the CPB;
- Patients in whom EtE alone has been added to the repair already performed, as a technique to reduce residual MR after first attempt of mitral valve repair;
- Patients operated both in median sternotomy or in minithoracotomy;
- Patients operated on at the Cardiac Surgery departmet of San Raffaele Hospital since January 1999 to December 2015.
Who cannot join
- Patients in whom other techniques have been used as a bailout procedure, concurrently or instead of EtE;
- Patients where the initial repair has been modified or undone;
- Patients whose mitral valve has been replaced.
Trial locations and contacts
1 site in 1 country.
About this study
The absence of residual mitral regurgitation (MR) after mitral valve repair is of paramount importance for the long term durability of the valve repair. Thus, ideally, after weaning from cardio-pulmonary by-pass (CPB) the trans-esophageal echocardiogram (TEE) should show no (or only trivial) residual MR, good coaptation length and no iatrogenic mitral valve stenosis. However, mild or more residual MR can be present in up to 4% of the patients after the initial mitral valve repair and a second CPB run may be necessary to improve the repair results. Mechanism of residual MR can be dynamic, related to systolic anterior motion (SAM) or to severe left ventricular dysfunction, and anatomical, related to residual prolapse, cleft, and suture or ring dehiscence. In several cases medical therapy can be effective in the management of the intra-operatively detected SAM, and residual cleft or suture dehiscence can be easily corrected during a second CPB run. However, in other cases SAM is not responsive to medical therapy or the residual MR jet would require complex and time-consuming techniques to be addressed, or even worse scenario, a mitral valve replacement could be necessary. In such cases the edge-to-edge (EE) technique can be used as a bail-out procedure. The anatomical characteristics of the mitral valve after an initial sub-optimal repair are certainly not ideal for the edge-to-edge technique, due to a possible significant reduction in the valve area, especially in case of posterior leaflet resection or small ring implanted. Nevertheless, in the short term the edge-to-edge technique used to rescue patients with sub-optimal initial repair resulted effective. However, the very long-term results of the edge-to-edge technique used as bail-out are not known. Thus, the aim of this study is to evaluate the clinical and echocardiographic results of the edge-to-edge technique used to rescue patients with initial sub-optimal mitral repair.
- Conditions
- Mitral Regurgitation
- Being tested
- Bailout edge to edge
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bailout edge to edgeProcedure or surgery
Edge to edge repair is the suture of the mitral valve leaflets in the regurgitant spot. It can be used as a bailout procedure when the first attempt of mitral valve repair with other surgical techniques is not satisfactory at intraoperative echo control. In this case, a second run of cardiopulmonary bypass is carried out, the heart is reopened and an edge-to-edge is performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: Up to 22 years
Reintervention for MR recurrency
Measured: Up to 22 years
MR recurrency
Measured: Up to 22 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start10 Jul 2021
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michele De Bonis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michele De Bonis, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733988
- Sponsor's protocol ID
- ETEB-SOR-VLT
- Status last verified
- Feb 2023
- First submitted
- 30 Jan 2023
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edge-To-Edge Technique Used as a Bailout in Case of Sub-Optimal Mitral Repair: Very Long-Term Results
- ClinicalTrials.gov ID
- NCT05733988
- Acronym / sponsor ID
- ETEB-SOR-VLT
- Conditions
- Mitral Regurgitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Michele De BonisUniversity, hospital or other
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 17 Feb 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 absence of residual mitral regurgitation (MR) after mitral valve repair is of paramount importance for the long term durability of the valve repair. Thus, ideally, after weaning from cardio-pulmonary by-pass (CPB) the trans-esophageal echocardiogram (TEE) should show no (or only trivial) residual MR, good coaptation length and no iatrogenic mitral valve stenosis. However, mild or more residual MR can be present in up to 4% of the patients after the initial mitral valve repair and a second CPB run may be necessary to improve the repair results. Mechanism of residual MR can be dynamic, related to systolic anterior motion (SAM) or to severe left ventricular dysfunction, and anatomical, related to residual prolapse, cleft, and suture or ring dehiscence. In several cases medical therapy can be effective in the management of the intra-operatively detected SAM, and residual cleft or suture dehiscence can be easily corrected during a second CPB run. However, in other cases SAM is not responsive to medical therapy or the residual MR jet would require complex and time-consuming techniques to be addressed, or even worse scenario, a mitral valve replacement could be necessary. In such cases the edge-to-edge (EE) technique can be used as a bail-out procedure. The anatomical characteristics of the mitral valve after an initial sub-optimal repair are certainly not ideal for the edge-to-edge technique, due to a possible significant reduction in the valve area, especially in case of posterior leaflet resection or small ring implanted. Nevertheless, in the short term the edge-to-edge technique used to rescue patients with sub-optimal initial repair resulted effective. However, the very long-term results of the edge-to-edge technique used as bail-out are not known. Thus, the aim of this study is to evaluate the clinical and echocardiographic results of the edge-to-edge technique used to rescue patients with initial sub-optimal mitral repair.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent a mitral valve repair surgery and in whom, at the intraoperative echo control, results where not satisfying, so an edge-to-edge repair was also performed as a bailout procedure
Key inclusion criteria (5 listed)
- Adult patients;
- Patients underwent mitral valve repair, with more than mild residual MR at the intraoperative TEE after leaving the CPB;
- Patients in whom EtE alone has been added to the repair already performed, as a technique to reduce residual MR after first attempt of mitral valve repair;
- Patients operated both in median sternotomy or in minithoracotomy;
- Patients operated on at the Cardiac Surgery departmet of San Raffaele Hospital since January 1999 to December 2015.
Key exclusion criteria (3 listed)
- Patients in whom other techniques have been used as a bailout procedure, concurrently or instead of EtE;
- Patients where the initial repair has been modified or undone;
- Patients whose mitral valve has been replaced.
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 |
|---|---|---|
| Bailout edge to edgeEdge to edge repair is the suture of the mitral valve leaflets in the regurgitant spot. It can be used as a bailout procedure when the first attempt of mitral valve repair with other surgical techniques is not satisfactory at intraoperative echo control. In this case, a second run of cardiopulmonary bypass is carried out, the heart is reopened and an edge-to-edge is performed. | Procedure or surgery | – |
Primary outcome
Mortality
Time frame: Up to 22 years
Reintervention for MR recurrency
Time frame: Up to 22 years
MR recurrency
Time frame: Up to 22 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- 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.
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 Mitral Regurgitation, run by Michele De Bonis at 1 site in Italy.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 17 Feb 2023. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality (time frame: Up to 22 years). The study lists 3 primary outcomes in all. 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 17 Feb 2023.