NCT05594420

Brief Summary

To identify the best approach for mitral valve replacement to decrease risk of bleeding and restrict blood transfusion and its complication.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

October 21, 2022

Last Update Submit

October 21, 2022

Conditions

Mitral Valve Disease

Outcome Measures

Primary Outcomes (2)

  • bleeding

    Amount of post operative bleeding per drains

    Baseline

  • Blood transfusion

    Amount of blood products transfused

    Baseline

Secondary Outcomes (4)

  • Reexploration

    Baseline

  • Complications of blood transfusion

    Baseline

  • ICU stay

    Baseline

  • Cost effectiveness

    Baseline

Study Arms (2)

MVR through Median sternotomy

Procedure: Mitral valve replacement

MVR through Minimally invasive approach

Procedure: Mitral valve replacement

Interventions

Mitral valve replacementPROCEDURE

Mitral valve replacement through median sternotomy and minimally invasive approach

MVR through Median sternotomyMVR through Minimally invasive approach

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged between 18-80 years old, males or females, undergoing mitral valve replacement through minimally invasive or median sternotomy at Assiut Cardiothoracic surgery department.

You may qualify if:

  • Patients undergoing mitral valve replacement through minimally invasive or median sternotomy at Assiut Cardiothoracic surgery department.

You may not qualify if:

  • Patients refused to be enrolled in research. Emergency, redo procedures, active infectious endocarditis, and combined surgery (valve surgery and coronary artery bypass graft).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Nishimura RA, Vahanian A, Eleid MF, Mack MJ. Mitral valve disease--current management and future challenges. Lancet. 2016 Mar 26;387(10025):1324-34. doi: 10.1016/S0140-6736(16)00558-4.

    PMID: 27025438BACKGROUND

  • Carpentier A, Loulmet D, Carpentier A, Le Bret E, Haugades B, Dassier P, Guibourt P. [Open heart operation under videosurgery and minithoracotomy. First case (mitral valvuloplasty) operated with success]. C R Acad Sci III. 1996 Mar;319(3):219-23. French.

    PMID: 8761668BACKGROUND

  • Sundermann SH, Sromicki J, Rodriguez Cetina Biefer H, Seifert B, Holubec T, Falk V, Jacobs S. Mitral valve surgery: right lateral minithoracotomy or sternotomy? A systematic review and meta-analysis. J Thorac Cardiovasc Surg. 2014 Nov;148(5):1989-1995.e4. doi: 10.1016/j.jtcvs.2014.01.046. Epub 2014 Feb 5.

    PMID: 24589199BACKGROUND

  • Al Otaibi A, Gupta S, Belley-Cote EP, Alsagheir A, Spence J, Parry D, Whitlock RP. Mini-thoracotomy vs. conventional sternotomy mitral valve surgery: a systematic review and meta-analysis. J Cardiovasc Surg (Torino). 2017 Jun;58(3):489-496. doi: 10.23736/S0021-9509.16.09603-8. Epub 2016 Sep 2.

    PMID: 27588617BACKGROUND

  • Modi P, Hassan A, Chitwood WR Jr. Minimally invasive mitral valve surgery: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2008 Nov;34(5):943-52. doi: 10.1016/j.ejcts.2008.07.057. Epub 2008 Sep 30.

    PMID: 18829343BACKGROUND

  • Eqbal AJ, Gupta S, Basha A, Qiu Y, Wu N, Rega F, Chu FV, Belley-Cote EP, Whitlock RP. Minimally invasive mitral valve surgery versus conventional sternotomy mitral valve surgery: A systematic review and meta-analysis of 119 studies. J Card Surg. 2022 May;37(5):1319-1327. doi: 10.1111/jocs.16314. Epub 2022 Feb 16.

    PMID: 35170791BACKGROUND

Central Study Contacts

Mustafa Loay Shehata

CONTACT

+201065896733musloay1996@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

October 21, 2022

First Posted

October 26, 2022

Study Start

December 1, 2022

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

October 26, 2022

Record last verified: 2022-10