Neochordae Technique in Mitral Valve Repair

Sponsor

National Heart Institute, Egypt (Other)

Overall Status

Unknown status

CT.gov ID

NCT04299334

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mitral Valve Prolapse Mitral Regurgitation	Procedure: adjustable neochordae Technique	Phase 1

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.

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

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Novel Adjustable Neochordae Technique in Mitral Valve Repair

Anticipated Study Start Date :

Mar 2, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Mar 1, 2022

Outcome Measures

Primary Outcome Measures

competency of mitral valve repair [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yosry Mahmoud Thakeb	El-Sheikh Zayed City	Giza	Egypt	12511

Sponsors and Collaborators

National Heart Institute, Egypt

Investigators

Principal Investigator: Yosry Thakeb, M.D., Cardiothoracic Surgery Department, National Heart Institute, Giza, Egypt.
Principal Investigator: Amr Zaher, M.D., Adjunct Professor, Biomedical sciences program, Zewail City of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yosry Mahmoud Thakeb, Principal Investigator, National Heart Institute, Egypt

ClinicalTrials.gov Identifier:

NCT04299334

Other Study ID Numbers:

NHI-MR-001

First Posted:

Mar 6, 2020

Last Update Posted:

Mar 9, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yosry Mahmoud Thakeb, Principal Investigator, National Heart Institute, Egypt

neochordae

Mitral valve repair

Additional relevant MeSH terms:

Mitral Valve Insufficiency

Mitral Valve Prolapse

Prolapse

Study Results

No Results Posted as of Mar 9, 2020