Neochordae Technique in Mitral Valve Repair

NCT ID: NCT04299334

Last Updated: 2020-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-02
• Study Completion Date: 2022-03-01

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.

Conditions

Mitral Valve Prolapse; Mitral Regurgitation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

adjustable 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart Institute, Egypt

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yosry Mahmoud Thakeb

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yosry Thakeb, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cardiothoracic Surgery Department, National Heart Institute, Giza, Egypt.

Amr Zaher, M.D.

Role: PRINCIPAL_INVESTIGATOR

Adjunct Professor, Biomedical sciences program, Zewail City of Science and Technology

Locations

Yosry Mahmoud Thakeb

El-Sheikh Zayed City, Giza Governorate, Egypt

Countries

Egypt

Central Contacts

Samar Sakr, BSc

Role: CONTACT

samarsakr@students.mans.edu.eg

+2 01020430546

Mahmoud Morsi, MBBCh

Role: CONTACT

mah.atef93@gmail.com

+2 01090032210

Facility Contacts

Yosry thakeb, M.D.

Role: primary

yosrythakeb@gmail.com

+2 01156760602

Other Identifiers

NHI-MR-001

Identifier Type: -

Identifier Source: org_study_id