Mitral Valve ProlapsePhase 1NCT04299334
Neochordae Technique in Mitral Valve Repair
A Phase 1 study testing adjustable neochordae Technique in people with Mitral Valve Prolapse and Mitral Regurgitation, run by National Heart Institute, Egypt at 1 site in Egypt.
Trial summary
Mitral valve (MV) repair has turned into a preferable option for surgeons over the MV replacement. Since the 1960s, Surgeons use this technique for more efficiency and durability. On the other hand, the proper determination of length and placement of artificial neochordae is still a challenge beyond this technique. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Mitral Valve Prolapse, Mitral Regurgitation
- What is being tested?
- adjustable neochordae Technique
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2020to 1 Mar 2022
- Phase
- Phase 1
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prolapsed or ruptured chordae
- Either degenerative or ischemic
Who cannot join
- Patient with redo Mitral Valve surgery
- Patient with severe rheumatic mitral stenosis (MS).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Yosry Mahmoud Thakeb
El-Sheikh Zayed City, Giza Governorate, 12511
Yosry thakeb, M.D., +2 01156760602, yosrythakeb@gmail.com
About this study
Official title: A Novel Adjustable Neochordae Technique in Mitral Valve Repair
Mitral valve (MV) repair has turned into a preferable option for surgeons over the MV replacement. Since the 1960s, Surgeons use this technique for more efficiency and durability. On the other hand, the proper determination of length and placement of artificial neochordae is still a challenge beyond this technique. These challenges are still a vital area for research and debate between surgeons and researchers.
In our novel technique,Investigators are not depending either on the preoperative investigations or intraoperative reference chordae in the adjustment of the optimal length of the neochordae, however, Researchers depend on the personal adjustment of the chordal length to the prolapsed scallop.
Read the detailed description
Mitral regurgitation (prolapse) and mitral stenosis are examples of diseases that affect the mitral valve. In mitral regurgitation, the leaflets do not close tightly and sway up and down allowing the blood to flow backward from the left ventricle into the left atrium. on the other hand, the mitral stenosis is caused by folding of thick leaflets of the valve which fuses together leading to low blood flow from the left atrium into the left ventricle and these cases are excluded from our trial. In mitral regurgitation, Surgeons prefer the mitral valve repair over the mitral valve replacement, But still, there are a lot of challenges towards this technique.
For decades, Surgeons used a lot of techniques to determine the length of neochordae includes that:
Determination of neochordal length by transoesophageal echocardiography or by using a landmark as a direct measurement. Previously, the surgeon applying the fixed loop length technique by using a custom-made caliper, and on the distance between the edge of a non-prolapsing segment and the tip of the papillary muscle (usually P1) to define the correct loop length. There are different types of papillary muscle and chordae as regards the shape, morphology, and length. So this reference distance is not fixed.
Adjusting neochordal length according to valve function. Length is chosen when the regurgitation is completely removed. Existing of a large number of neochordae will make this process more complex for the surgeon to decide.
Mitral valve (MV) repair has turned into a preferable option for surgeons over the MV replacement. Since the 1960s, Surgeons use this technique for more efficiency and durability. On the other hand, the proper determination of length and placement of artificial neochordae is still a challenge beyond this technique. These challenges are still a vital area for research and debate between surgeons and researchers.
In our novel technique, Investigators are not depending either on the preoperative investigations or intraoperative reference chordae in the adjustment of the optimal length of the neochordae, however, Researchers depend on the personal adjustment of the chordal length to the prolapsed scallop.
- Conditions
- Mitral Valve Prolapse, Mitral Regurgitation
- Being tested
- adjustable neochordae Technique
- Keywords
- neochordae, Mitral valve repair
- Medical subject headings
- Mitral Valve Prolapse, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjustable neochordae TechniqueProcedure or surgery
Classic ring annuloplasty will be done using Carpentier or physio ring, then neochordal placement will be done using the looping technique. The length of the chordae is adjusted to achieve the optimal length.
In this study, Surgeons use relatively short loops because of the augmentation of the length with extra loops suspended with Gortex. Placement of at least 8-12 chordae of the corresponding heads of the papillary muscle tip to achieve proper management of the prolapse and longevity of the repair.
What is being measured
The primary outcome is the main question the study is designed to answer.
competency of mitral valve repair
by using the transthoracic echocardiography or the trans-esophageal echo to measure the mitral valve competency and the degree of mitral regurge.
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start2 Mar 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Institute, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yosry Mahmoud Thakeb, National Heart Institute, Egypt
- Investigators
- Yosry Thakeb, M.D., Principal investigator, Cardiothoracic Surgery Department, National Heart Institute, Giza, Egypt.Amr Zaher, M.D., Principal investigator, Adjunct Professor, Biomedical sciences program, Zewail City of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299334
- Sponsor's protocol ID
- NHI-MR-001
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Adjustable Neochordae Technique in Mitral Valve Repair
- ClinicalTrials.gov ID
- NCT04299334
- Acronym / sponsor ID
- NHI-MR-001
- Conditions
- Mitral Valve Prolapse, Mitral Regurgitation
- Keywords
- neochordae, Mitral valve repair
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Heart Institute, EgyptOther government
- Study start
- 2 Mar 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 6 Mar 2020 (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.
Mitral valve (MV) repair has turned into a preferable option for surgeons over the MV replacement. Since the 1960s, Surgeons use this technique for more efficiency and durability. On the other hand, the proper determination of length and placement of artificial neochordae is still a challenge beyond this technique. These challenges are still a vital area for research and debate between surgeons and researchers.
In our novel technique,Investigators are not depending either on the preoperative investigations or intraoperative reference chordae in the adjustment of the optimal length of the neochordae, however, Researchers depend on the personal adjustment of the chordal length to the prolapsed scallop.
Detailed description
Mitral regurgitation (prolapse) and mitral stenosis are examples of diseases that affect the mitral valve. In mitral regurgitation, the leaflets do not close tightly and sway up and down allowing the blood to flow backward from the left ventricle into the left atrium. on the other hand, the mitral stenosis is caused by folding of thick leaflets of the valve which fuses together leading to low blood flow from the left atrium into the left ventricle and these cases are excluded from our trial. In mitral regurgitation, Surgeons prefer the mitral valve repair over the mitral valve replacement, But still, there are a lot of challenges towards this technique.
For decades, Surgeons used a lot of techniques to determine the length of neochordae includes that:
Determination of neochordal length by transoesophageal echocardiography or by using a landmark as a direct measurement. Previously, the surgeon applying the fixed loop length technique by using a custom-made caliper, and on the distance between the edge of a non-prolapsing segment and the tip of the papillary muscle (usually P1) to define the correct loop length. There are different types of papillary muscle and chordae as regards the shape, morphology, and length. So this reference distance is not fixed.
Adjusting neochordal length according to valve function. Length is chosen when the regurgitation is completely removed. Existing of a large number of neochordae will make this process more complex for the surgeon to decide.
Mitral valve (MV) repair has turned into a preferable option for surgeons over the MV replacement. Since the 1960s, Surgeons use this technique for more efficiency and durability. On the other hand, the proper determination of length and placement of artificial neochordae is still a challenge beyond this technique. These challenges are still a vital area for research and debate between surgeons and researchers.
In our novel technique, Investigators are not depending either on the preoperative investigations or intraoperative reference chordae in the adjustment of the optimal length of the neochordae, however, Researchers depend on the personal adjustment of the chordal length to the prolapsed scallop.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Prolapsed or ruptured chordae
- Either degenerative or ischemic
Key exclusion criteria (2 listed)
- Patient with redo Mitral Valve surgery
- Patient with severe rheumatic mitral stenosis (MS).
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 |
|---|---|---|
| adjustable neochordae TechniqueClassic ring annuloplasty will be done using Carpentier or physio ring, then neochordal placement will be done using the looping technique. The length of the chordae is adjusted to achieve the optimal length. In this study, Surgeons use relatively short loops because of the augmentation of the length with extra loops suspended with Gortex. Placement of at least 8-12 chordae of the corresponding heads of the papillary muscle tip to achieve proper management of the prolapse and longevity of the repair. | Procedure or surgery | – |
Primary outcome
competency of mitral valve repair
Time frame: 6 months follow up
by using the transthoracic echocardiography or the trans-esophageal echo to measure the mitral valve competency and the degree of mitral regurge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
Yosry Thakeb, M.D. principal investigator
Cardiothoracic Surgery Department, National Heart Institute, Giza, Egypt.
Amr Zaher, M.D. principal investigator
Adjunct Professor, Biomedical sciences program, Zewail City of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing adjustable neochordae Technique in people with Mitral Valve Prolapse and Mitral Regurgitation, run by National Heart Institute, Egypt 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: status not confirmed, as of the sponsor's last update on 9 Mar 2020. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Samar Sakr, BSc (+2 01020430546, samarsakr@students.mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
competency of mitral valve repair (time frame: 6 months follow up). 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 9 Mar 2020.