Neochordae Technique in Mitral Valve Repair

NCT04299334 | Unknown Phase 1

• 1 other identifier: NHI-MR-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Valve Prolapse; Mitral Regurgitation

Keywords

neochordae; Mitral valve repair

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months follow up

Interventions

adjustable neochordae Technique PROCEDURE

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.

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prolapsed or ruptured chordae
• Either degenerative or ischemic

You may not qualify if:

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

Sponsors & Collaborators

• National Heart Institute, Egypt: lead

Study Sites (1)

Yosry Mahmoud Thakeb

El-Sheikh Zayed City, Giza Governorate, 12511, Egypt

Location

MeSH Terms

Conditions

Mitral Valve Prolapse; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Prolapse; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samar Sakr, BSc

CONTACT

+2 01020430546; samarsakr@students.mans.edu.eg

Mahmoud Morsi, MBBCh

CONTACT

+2 01090032210; mah.atef93@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 6, 2020
• Study Start: March 2, 2020
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: March 9, 2020

Record last verified: 2020-03

Locations

EG (1)