Mitral Valve Surgical ApproachesNCT04078100
Transseptal Approach Versus Conventional Left Atrial Approach for Mitral Valve Procedures
An observational study of Mitral Valve Surgical Approaches, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Mitral Valve Surgical Approaches
- What is being tested?
- Transseptal approach.
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 30 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with congenital mitral valve diseases .
- patient refused to sign the informed consent to be a part in the research .
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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 .
- Conditions
- Mitral Valve Surgical Approaches
- Being tested
- Transseptal approach.
- Keywords
- mitral valve replacement, transseptal approach, left atrial approach, mital valve repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transseptal approach.Procedure or surgery
surgical approach to the mitral valve through the Fossa Ovalis by way of the right atrium.
| Study group | Role | What they receive |
|---|---|---|
| group A | underwent mitral valve surgery through transseptal approach. Receives: Procedure: Transseptal approach. | |
| group B | underwent mitral valve surgery through conventional left atrial approach. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ischemic time
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.
Measured: intraoperative registration.
whole operation time.
period of time from skin incision to skin closure in open heart surgery.
Measured: intraoperative registration.
re-operation
re exploration through the same incision site to stop bleeding.
Measured: with in the first 24 hrs post operative.
Secondary outcomes (2)
Postoperative arrhythmias.
newly arising tachy or bradyarrhythmia
Measured: within the first week post operative.
Hospital stay.
time of hospital admission postoperative.
Measured: up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start1 Sep 2019 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve Surgical ApproachesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beshoy Allam Moris, Assiut University
- Investigators
- Mahmoud Thabet, dr., Study director, general surgery department, AssiutUMohamed Mahmoud, dr., Study director, cardiothoracic department, AssiutU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078100
- Sponsor's protocol ID
- Transseptal apprroach
- Status last verified
- Sep 2019
- First submitted
- 2 Sep 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rezahosseini O, Rezaei M, Ahmadi Tafti SH, Jalali A, Bina P, Ghiasi A, Karimi A, Abbasi K, Shirzad M, Davoodi S, Salehi Omran A. Transseptal Approach versus Left Atrial Approach to Mitral Valve: A Propensity Score Matching Study. J Tehran Heart Cent. 2015 Oct 27;10(4):188-93.
PubMed 26985207van der Merwe J, Casselman F. Mitral Valve Replacement-Current and Future Perspectives. Open J Cardiovasc Surg. 2017 Jul 13;9:1179065217719023. doi: 10.1177/1179065217719023. eCollection 2017.
PubMed 28757798Doty JR, Caine WT. Mitral valve replacement and tricuspid valve repair through a transseptal approach for double-valve endocarditis. Multimed Man Cardiothorac Surg. 2012 Jan 1;2012:mms003. doi: 10.1093/mmcts/mms003.
PubMed 24414707Nienaber JJ, Glower DD. Minitransseptal versus left atrial approach to the mitral valve: a comparison of outcomes. Ann Thorac Surg. 2006 Sep;82(3):834-9; discussion 839. doi: 10.1016/j.athoracsur.2006.04.014.
PubMed 16928494Santibanez Escobar F, Serrano Gallardo G, Ramirez Marroquin S, Lopez Soriano F, Barragan Garcia R. The transseptal approach for mitral valve replacement revisited. Tex Heart Inst J. 1997;24(3):209-14.
PubMed 9339510
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transseptal Approach Versus Conventional Left Atrial Approach for Mitral Valve Procedures
- ClinicalTrials.gov ID
- NCT04078100
- Acronym / sponsor ID
- Transseptal apprroach
- Conditions
- Mitral Valve Surgical Approaches
- Keywords
- mitral valve replacement, transseptal approach, left atrial approach, mital valve repair
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | Procedure: Transseptal approach.underwent mitral valve surgery through transseptal approach. |
| group B | – | –underwent mitral valve surgery through conventional left atrial approach. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with congenital mitral valve diseases .
- patient refused to sign the informed consent to be a part in the research .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transseptal approach.surgical approach to the mitral valve through the Fossa Ovalis by way of the right atrium. | Procedure or surgery | group A |
Primary outcome
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.
whole operation time.
Time frame: intraoperative registration.
period of time from skin incision to skin closure in open heart surgery.
re-operation
Time frame: with in the first 24 hrs post operative.
re exploration through the same incision site to stop bleeding.
2 secondary outcomes
Postoperative arrhythmias.
Time frame: within the first week post operative.
Hospital stay.
Time frame: up to three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Background: PubMed 26985207Rezahosseini O, Rezaei M, Ahmadi Tafti SH, Jalali A, Bina P, Ghiasi A, Karimi A, Abbasi K, Shirzad M, Davoodi S, Salehi Omran A. Transseptal Approach versus Left Atrial Approach to Mitral Valve: A Propensity Score Matching Study. J Tehran Heart Cent. 2015 Oct 27;10(4):188-93.
- Background: PubMed 28757798van der Merwe J, Casselman F. Mitral Valve Replacement-Current and Future Perspectives. Open J Cardiovasc Surg. 2017 Jul 13;9:1179065217719023. doi: 10.1177/1179065217719023. eCollection 2017.
- Background: PubMed 24414707Doty JR, Caine WT. Mitral valve replacement and tricuspid valve repair through a transseptal approach for double-valve endocarditis. Multimed Man Cardiothorac Surg. 2012 Jan 1;2012:mms003. doi: 10.1093/mmcts/mms003.
- Background: PubMed 16928494Nienaber JJ, Glower DD. Minitransseptal versus left atrial approach to the mitral valve: a comparison of outcomes. Ann Thorac Surg. 2006 Sep;82(3):834-9; discussion 839. doi: 10.1016/j.athoracsur.2006.04.014.
- Background: PubMed 9339510Santibanez Escobar F, Serrano Gallardo G, Ramirez Marroquin S, Lopez Soriano F, Barragan Garcia R. The transseptal approach for mitral valve replacement revisited. Tex Heart Inst J. 1997;24(3):209-14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Thabet, dr. study director
general surgery department, AssiutU
Mohamed Mahmoud, dr. study director
cardiothoracic department, AssiutU
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Surgical Approaches, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beshoy Allam, master (+201009471147, beshoui011145@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ischemic time (time frame: intraoperative registration.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04078100, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.