Neochordae Technique in Mitral Valve Repair

NCT04299334 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-03-09

No results posted yet for this study

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

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • National Heart Institute, Egypt

    lead OTHER_GOV

Principal Investigators

  • Yosry Thakeb, M.D. · Cardiothoracic Surgery Department, National Heart Institute, Giza, Egypt.

  • Amr Zaher, M.D. · Adjunct Professor, Biomedical sciences program, Zewail City of Science and Technology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-02
Primary Completion
2021-12-01
Completion
2022-03-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04299334 on ClinicalTrials.gov