Mitral Valve Posterior Leaflet ProlapseNCT06778369
Triangular Exclusion Technique in Isolated Posterior Mitral Valve Leaflet Prolapse for Mitral Valve Repair
A study testing traingular exclusion technique in mitral valve repair in people with Mitral Valve Posterior Leaflet Prolapse, run by Zagazig University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if surgical method done to repair one of the heart valve called mitral valve disease during open heart surgery The main questions aims to answer is: Does this method is safe and effective for long time and can be used in special cases of mitral valve surgery ? participants… Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Mitral Valve Posterior Leaflet Prolapse
- What is being tested?
- traingular exclusion technique in mitral valve repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2020to 15 Jun 2023
- Phase
- Interventional
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- varying degrees of degenerative MV regurgitation, ranging from moderate to severe or severe caused by isolated prolapse of the posterior MV leaflet
- concomitant tricuspid annuloplasty
Who cannot join
- with Mitral Valve stenosis or any other manifestation of mitral regurgitation pathology.
- individuals requiring surgical intervention for the aortic or pulmonary valves
Trial locations and contacts
1 site in 1 country.
Egypt1 site
cardiothorathic surgery department -faculty of medecine-zagazig univeristy-Egypt
Zagazig, Sharqia Province, 44519
About this study
The goal of this clinical trial is to learn if surgical method done to repair one of the heart valve called mitral valve disease during open heart surgery
The main questions aims to answer is:
Does this method is safe and effective for long time and can be used in special cases of mitral valve surgery ? participants come to clinic to be checked clinically and radiologcally every month by the surgeon till 12 month
Read the detailed description
the surgical method isThe prolapsed part of the posterior leaflet of the mitral valve is inverted and excluded, toward the left ventricle but not cutted echocardiography done before participants leave hospital after sugery, after 6 month and after 12 months to confirm that this method of repair is safe and effective for participants life long
- Conditions
- Mitral Valve Posterior Leaflet Prolapse
- Being tested
- traingular exclusion technique in mitral valve repair
- Keywords
- Mitral valve repair;Triangular Exclusion Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traingular exclusion technique in mitral valve repairProcedure or surgery
The prolapsed part of the posterior leaflet is inverted and excluded, not resected toward the left ventricle, and the margins of the prolapsed part are sutured to each other's using proline 5/0, extending from the posterior leaflet edge to the posterior annulus. Then the posterior annulus is reinforced with an annuloplasty band using a treated strip of pericardium. The determination of suitable ring size is subsequently predicated upon the assessment of inter-commissural distance surface area and the anterior leaflet, utilizing sizers that are correlated with typical mitral geometry.
| Study group | Role | What they receive |
|---|---|---|
| traingular exclusion technique | Experimental | Triangular exclusion technique in isolated posterior mitral valve leaflet prolapse for mitral valve repair Receives: Procedure: traingular exclusion technique in mitral valve repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of postoperative mitral valve regurgitation following Triangular Exclusion Technique
Suggested Quality Metrics for Interventions for Mitral Regurgitation
- Procedural success Absence of moderate or worse residual mitral regurgitation (on TTE within 30 days) Absence of stroke or mortality
- Procedural effectiveness (1 year) Alive Freedom from moderate or worse mitral regurgitation Freedom from cardiovascular reintervention Freedom from NYHA functional class III-IV symptoms
- Durability (5 years or later) Freedom from moderate or worse mitral regurgitation Freedom from mitral valve reintervention But our study limited to only 1 year follow up due to our academic authorities that will be added as one of the strong limitations of our study but we will mention at conclusion and recommendations to extend the sample size and follow up period of the operated patients till 5 years in the following studies that interested by the same topic
Measured: about 13 months From enrolment to the end of surgical procedure about one month follow up Echo done after 6 and 12 months so total time frame about 13 months duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start15 Jun 2020
- Primary completion20 Apr 2022
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve Posterior Leaflet ProlapseStudies 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
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sameh Elsayed Saeed Elsayed, Zagazig University
- Investigators
- sameh saeed, lecturer, Principal investigator, cardiothoracic surgery department-faculty of medecine-Zagazig univeristy-Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778369
- Sponsor's protocol ID
- ZU-IRB # 11120-20-9-2023
- Status last verified
- Jan 2025
- First submitted
- 27 Dec 2024
- Last updated
- 16 Jan 2025
- 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 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triangular Exclusion Technique in Isolated Posterior Mitral Valve Leaflet Prolapse for Mitral Valve Repair
- ClinicalTrials.gov ID
- NCT06778369
- Acronym / sponsor ID
- ZU-IRB # 11120-20-9-2023
- Conditions
- Mitral Valve Posterior Leaflet Prolapse
- Keywords
- Mitral valve repair;Triangular Exclusion Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 16 Jan 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.
The goal of this clinical trial is to learn if surgical method done to repair one of the heart valve called mitral valve disease during open heart surgery
The main questions aims to answer is:
Does this method is safe and effective for long time and can be used in special cases of mitral valve surgery ? participants come to clinic to be checked clinically and radiologcally every month by the surgeon till 12 month
Detailed description
the surgical method isThe prolapsed part of the posterior leaflet of the mitral valve is inverted and excluded, toward the left ventricle but not cutted echocardiography done before participants leave hospital after sugery, after 6 month and after 12 months to confirm that this method of repair is safe and effective for participants life long
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| traingular exclusion technique | Experimental | Procedure: traingular exclusion technique in mitral valve repairTriangular exclusion technique in isolated posterior mitral valve leaflet prolapse for mitral valve repair |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- varying degrees of degenerative MV regurgitation, ranging from moderate to severe or severe caused by isolated prolapse of the posterior MV leaflet
- concomitant tricuspid annuloplasty
Key exclusion criteria (2 listed)
- with Mitral Valve stenosis or any other manifestation of mitral regurgitation pathology.
- individuals requiring surgical intervention for the aortic or pulmonary valves
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 |
|---|---|---|
| traingular exclusion technique in mitral valve repairThe prolapsed part of the posterior leaflet is inverted and excluded, not resected toward the left ventricle, and the margins of the prolapsed part are sutured to each other's using proline 5/0, extending from the posterior leaflet edge to the posterior annulus. Then the posterior annulus is reinforced with an annuloplasty band using a treated strip of pericardium. The determination of suitable ring size is subsequently predicated upon the assessment of inter-commissural distance surface area and the anterior leaflet, utilizing sizers that are correlated with typical mitral geometry. | Procedure or surgery | traingular exclusion technique |
Primary outcome
degree of postoperative mitral valve regurgitation following Triangular Exclusion Technique
Time frame: about 13 months From enrolment to the end of surgical procedure about one month follow up Echo done after 6 and 12 months so total time frame about 13 months duration
Suggested Quality Metrics for Interventions for Mitral Regurgitation 1. Procedural success Absence of moderate or worse residual mitral regurgitation (on TTE within 30 days) Absence of stroke or mortality 2. Procedural effectiveness (1 year) Alive Freedom from moderate or worse mitral regurgitation Freedom from cardiovascular reintervention Freedom from NYHA functional class III-IV symptoms 3. Durability (5 years or later) Freedom from moderate or worse mitral regurgitation Freedom from mitral valve reintervention But our study limited to only 1 year follow up due to our academic authorities that will be added as one of the strong limitations of our study but we will mention at conclusion and recommendations to extend the sample size and follow up period of the operated patients till 5 years in the following studies that interested by the same topic
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 16 Jan 2025.
- Individual participant dataSharing planned: No
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.
sameh saeed, lecturer principal investigator
cardiothoracic surgery department-faculty of medecine-Zagazig univeristy-Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traingular exclusion technique in mitral valve repair in people with Mitral Valve Posterior Leaflet Prolapse, run by Zagazig University at 1 site in Egypt.
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 2 inclusion and 2 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 16 Jan 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 Egypt. 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?
degree of postoperative mitral valve regurgitation following Triangular Exclusion Technique (time frame: about 13 months From enrolment to the end of surgical procedure about one month follow up Echo done after 6 and 12 months so total time frame about 13 months duration). 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 16 Jan 2025.