Transseptal Approach Versus Conventional Left Atrial Approach for Mitral Valve Procedures

September 3, 2019 updated by: Beshoy Allam Moris, Assiut University

Study Objectives/Specific Aims Overall Goal: To compare between transseptal approach and the conventional left atrial approach for mitral valve procedures.

  • Objective 1: Assess the intraoperative approach related criteria in valve exposure, cardiopulmonary bypass time and intraoperative complications.
  • Objective 2: Assess the outcomes and postoperative results.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Mitral valve diseases are considered among the most prevalent valvular heart diseases that necessitate surgical intervention.

as the Modern international guidelines substantially recommend mitral valve repair whenever possible there is significant decrease in mitral valve replacement rates.

Cardiothoracic surgeons have to face the problem of Making a decision regarding mitral valve repair, reconstruction or replacement which requires excellent valve exposure for precise anatomical definition and manipulation taking in mind cases with specific anatomical challenges.

Since the beginning of modern cardiac surgery only two basic approaches to the mitral valve have been described by Effler who wrote in 1958 " the actual entry into the left atrium may be accomplished in either of two ways : through the Fossa Ovalis by way of the right atrium or through the posterior interatrial groove " Nowadays median sternotomy is still the most commonly used incision for mitral valve surgery which allows the best exposure for the valve through transseptal incision or through Sandergaard's groove.

Although the latter approach is the preferred method for most surgeons the transseptal approach has been revisited in more recent years in various forms by those seeking better exposure of mitral valve especially in cases with difficult anatomy.

In this paper we try to compare the transseptal approach with the conventional left atrial approach for mitral valve procedures to review previous literatures' results and to clarify the effect of using each of the two approaches in preoperative ,intra and postoperative course .

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all patients who presented to Cardiothoracic Surgery Department, Assiut University Hospital and who meet the listed inclusion from 2016 to 2019 within the range of 100 eligible case.

Description

Inclusion Criteria:

  • Patients underwent mitral valve replacement, mitral valve repair, redo mitral valve replacement, combined mitral and tricuspid procedures, combined mitral surgery and coronary arteries bypass graft at cardiothoracic surgery department Assiut University Hospital.

Exclusion Criteria:

  • Patients with congenital mitral valve diseases .
  • patient refused to sign the informed consent to be a part in the research .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group A
underwent mitral valve surgery through transseptal approach.
Procedure: Transseptal approach.
surgical approach to the mitral valve through the Fossa Ovalis by way of the right atrium.
group B
underwent mitral valve surgery through conventional left atrial approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ischemic time
Time Frame: intraoperative registration.
period of time from applying the aortic cross clamp till its removal in open heart surgeries during which there is no blood flow in the coronary arteries and the heart is ischemic.
intraoperative registration.
whole operation time.
Time Frame: intraoperative registration.
period of time from skin incision to skin closure in open heart surgery.
intraoperative registration.
re-operation
Time Frame: with in the first 24 hrs post operative.
re exploration through the same incision site to stop bleeding.
with in the first 24 hrs post operative.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative arrhythmias.
Time Frame: within the first week post operative.
newly arising tachy or bradyarrhythmia
within the first week post operative.
Hospital stay.
Time Frame: up to three months
time of hospital admission postoperative.
up to three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Mahmoud Thabet, dr., general surgery department, AssiutU
  • Study Director: Mohamed Mahmoud, dr., cardiothoracic department, AssiutU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

September 30, 2020

Study Completion (Anticipated)

October 30, 2020

Study Registration Dates

First Submitted

September 2, 2019

First Submitted That Met QC Criteria

September 3, 2019

First Posted (Actual)

September 4, 2019

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Transseptal apprroach

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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