Skip to main content
Clinical Trials/NCT04299334
NCT04299334
Unknown
Phase 1

A Novel Adjustable Neochordae Technique in Mitral Valve Repair

National Heart Institute, Egypt1 site in 1 country30 target enrollmentMarch 2, 2020

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Mitral Valve Prolapse
Sponsor
National Heart Institute, Egypt
Enrollment
30
Locations
1
Primary Endpoint
competency of mitral valve repair
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2, 2020
End Date
March 1, 2022
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
National Heart Institute, Egypt
Responsible Party
Principal Investigator
Principal Investigator

Yosry Mahmoud Thakeb

Principal Investigator

National Heart Institute, Egypt

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).

Outcomes

Primary Outcomes

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.

Study Sites (1)

Loading locations...

Similar Trials