Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement

NCT05438433 | Completed DMC FDA Device

• 1 other identifier: 2796#
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Are there differences in outcome of mitral valve replacement with preservation of mitral apparatus among rheumatic and/or ischemic mitral lesions?. Mitral valve replacement with preservation of leaflets, and added coronary artery-bypass surgery, when indicated, is it a feasible and reproducible procedure?. The study was designed to compare outcome after prosthetic mitral replacement with preservation of mitral apparatus for rheumatic valve disease with outcome of replacement for ischemic myocardium and mitral valve disease, The outcomes will be guided by clinical assessment. and echo-cardiograph.

Conditions

Diseases of Mitral Valves; Abnormality of Mitral Valve Annulus (Disorder); Mitral Valve Replacement

Keywords

: Preservation of mitral apparatus ,; mitral valve replacement; Rheumatic valve disease and ischemia

Outcome Measures

Primary Outcomes (14)

• Smoking index

  Number of Packs every day X number of years of smoking= Pack.year,

  One week before surgery(or during first clinical visit) .

• Age and gender for each participant

  Males above 40 years and Females above 45 years need pre-operative coronary angio-graph

  One week before surgery .

• For each participant: pathological:type of mitral valve lesion

  severe stenosis with mitral area \< 1 cm square, severe regurgitation, or mixed lesions

  Seven days before surgery .

• For each participant: etiological :type of mitral valve lesion

  Rheumatic: distorted thickened leaflets,thickened fibrosed chordae

  Seven days before surgery .

• For each participant: etiological :type of mitral valve lesion

  Rheumatic: distorted thickened leaflets,thickened fibrosed chordae or ischemic incompetence

  Seven days before surgery- echo-cardiograph.

• For each participant:, assessing sub-valvular apparatus

  Thickened chordae, ruptured chordae, ischemia of papillary muscles or lateral ventricular wall.

  One week before surgery. with Echo-cardiograph.

• Abascal echo-cardiographic mitral valve score (Wilkins score)

  :if score is 8 or less it is good for balloon valvo-plasty, if \> 8 surgery is recommended ( leaflet mobility, thickness and calcification. Fourthly, sub-valvular thickening., higher scores = more deterioration

  One week before surgery.with Echo-cardiograph

• left ventricular wall motion abnormality

  hypokinesia, Akinesia, Dyskinesia of certain segment(s)

  one week before surgery - with an echo-cardiograph

• Number of participants with Signs of left ventricular dysfunction

  low ejection fraction \<52%, low stroke volume\< 70 ml, low cardiac output \<5 litres per minute

  seven days before surgery echo-cardiograph examination

• Number of participants with pre-operative coronary artery disease

  Expected on clinical bases and .proved by Echo-cardiograph-findings

  seven days before surgery, coronary angio-graph

• Number of participants with pre-operative ischemic complications

  left ventricular thrombi, septal and left ventricular wall thickness in mm .

  seven days before surgery echo-cardiograph examination

• Assessment of any evolving new prosthetic valve dysfunction

  Left atrioventricular outflow stenosis, prosthetic dysfunction due to preservation of valve apparatus

  intra-operative trans-esophageal echo-cardiograph examination

• Change in post-operative left ventricular functions

  : Low Fractional Shortening \< 28% , Ejection fraction \< 40%,, increased left ventricular dimensions and volume

  5 days post-operatively and end of 6th and 12 months after surgery with Echo-Cardiograph

• Change of Prosthetic mitral valve functions

  Development of para-valvular leak or central jet of regurgitation or stuck valve by a thrombus

  Monthly through study completion up to 12 months after surgery..... with Echo-cardiograph

Secondary Outcomes (3)

• changes on Clinical examination

  Monthly up to 12 months after surgery)

• Changes in Results of Prothrombin time, concentration and.International normalized ratio

  .Monthly through study completion up to 12 months.

• Mortality and Morbidity

  Monthly through study completion up to 12 months.

Study Arms (2)

Group A

SHAM COMPARATOR

50 patients with isolated rheumatic mitral valve disease (group A)

Device: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets

Group B

OTHER

50 patients with mitral disease and myocardial ischemia (group B)

Device: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets

Interventions

St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets DEVICE

St.Jude prosthetic(FDA approved) mitral valve replacement with or without coronary artery bypass grafts

Also known as: St.Jude bi leaflet prosthesis to replace diseased valve with preservation of leaflets with Myocardial re-vascularization, St.Jude prosthetic mitral replacement with preservation of valve apparatus and bypass grafts for associated coronary artery disease

Group A; Group B

Eligibility Criteria

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

You may qualify if:

• Mitral stenosis (MS)
• symptoms are severely limiting and cannot be managed with diuresis and heart rate control.
• Mitral regurgitation(MR):
• \* acute severe MR require surgical correction for hemo-dynamics and relief of symptoms .
• Chronic primary mitral regurgitation:
• \* rheumatic heart disease: replacement before irreversible changes occur can be curative.
• Mixed Mitral Stenosis and Mitral Regurgitation:
• If beta blockers and diuretics do not relieve symptoms, replacement should be performed only in patients who have severe limiting symptoms.
• Myocardial ischemia associating or complicated with miral valve disease.

You may not qualify if:

• Patients showing good response to medical therapy, and Cases complicated by:
• ineffective endocarditis,
• previous myocardial re-vascularization
• ischemic ventricular septal defect,
• left ventricular aneurysm,
• Ruptured papillary muscles of mitral apparatus.

Sponsors & Collaborators

• Suez Canal University: lead
• National Research Centre, Egypt: collaborator

Study Sites (2)

Suez Canal University

Ismailia, +064, Egypt

Location

Suez Canal University

Ismailia, 002-064, Egypt

Location

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed A. allaban, PhD

  Suez Canal University, FOM- Research Ethics Committee

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: All roles were unmasked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. of Cardio-thoracic Surgery

Model Details: both groups of patients received surgical treatment parallel to each other.

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 30, 2022
• Study Start: December 28, 2016
• Primary Completion: January 1, 2020
• Study Completion: December 28, 2021
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 360 days
• Access Criteria: h.dosoky@yahoo.com

Locations

EG (2)