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Neochordae Technique in Mitral Valve Repair

A Novel Adjustable Neochordae Technique in Mitral Valve Repair

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04299334
Enrollment
30
Registered
2020-03-06
Start date
2020-03-02
Completion date
2022-03-01
Last updated
2020-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Regurgitation, Mitral Valve Prolapse

Keywords

neochordae, Mitral valve repair

Brief 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. 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.

Interventions

PROCEDUREadjustable neochordae Technique

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.

Sponsors

National Heart Institute, Egypt
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Prolapsed or ruptured chordae * Either degenerative or ischemic

Exclusion criteria

* Patient with redo Mitral Valve surgery * Patient with severe rheumatic mitral stenosis (MS).

Design outcomes

Primary

MeasureTime frameDescription
competency of mitral valve repair6 months follow upby using the transthoracic echocardiography or the trans-esophageal echo to measure the mitral valve competency and the degree of mitral regurge.

Countries

Egypt

Contacts

Primary ContactSamar Sakr, BSc
samarsakr@students.mans.edu.eg+2 01020430546
Backup ContactMahmoud Morsi, MBBCh
mah.atef93@gmail.com+2 01090032210

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026