Clinical trial NCT04299334: Neochordae Technique in Mitral Valve Repair
Official title: A Novel Adjustable Neochordae Technique in Mitral Valve Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Mitral Valve Prolapse
Mitral Regurgitation
Keywords: neochordae
Mitral valve repair
Lead sponsor: National Heart Institute, Egypt
Sponsor class: OTHER_GOV
First posted: 2020-03-06
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: competency of mitral valve repair
timeFrame: 6 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: El-Sheikh Zayed City
country: Egypt
facility: Yosry Mahmoud Thakeb
state: Giza
Study officials:
affiliation: Cardiothoracic Surgery Department, National Heart Institute, Giza, Egypt.
name: Yosry Thakeb, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Adjunct Professor, Biomedical sciences program, Zewail City of Science and Technology
name: Amr Zaher, M.D.
role: PRINCIPAL_INVESTIGATOR
References: