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Neochordae Technique in Mitral Valve Repair

Primary Purpose

Mitral Valve Prolapse, Mitral Regurgitation

Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
adjustable neochordae Technique
Sponsored by
National Heart Institute, Egypt
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Prolapse focused on measuring neochordae, Mitral valve repair

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Yosry Mahmoud Thakeb

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 4, 2020
Last Updated
March 5, 2020
Sponsor
National Heart Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT04299334
Brief Title
Neochordae Technique in Mitral Valve Repair
Official Title
A Novel Adjustable Neochordae Technique in Mitral Valve Repair
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2020 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Heart Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Prolapse, Mitral Regurgitation
Keywords
neochordae, Mitral valve repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
adjustable neochordae Technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
competency of mitral valve repair
Description
by using the transthoracic echocardiography or the trans-esophageal echo to measure the mitral valve competency and the degree of mitral regurge.
Time Frame
6 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samar Sakr, BSc
Phone
+2 01020430546
Email
samarsakr@students.mans.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Morsi, MBBCh
Phone
+2 01090032210
Email
mah.atef93@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yosry Thakeb, M.D.
Organizational Affiliation
Cardiothoracic Surgery Department, National Heart Institute, Giza, Egypt.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amr Zaher, M.D.
Organizational Affiliation
Adjunct Professor, Biomedical sciences program, Zewail City of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yosry Mahmoud Thakeb
City
El-Sheikh Zayed City
State/Province
Giza
ZIP/Postal Code
12511
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yosry thakeb, M.D.
Phone
+2 01156760602
Email
yosrythakeb@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Neochordae Technique in Mitral Valve Repair

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