Minimally Invasive Mitral Valve SurgeryNCT05504109
Minimally Invasive Mitral Valve Replacement Versus Conventional Approach: Comparison of Early Postoperative Outcomes.
A study testing mitral valve replacement through full sternotomy approach. and mitral valve replacement through right mini thoracotomy approach. in people with Minimally Invasive Mitral Valve Surgery, run by Sohag University at 1 site in Egypt.
Trial summary
The term minimally invasive mitral valve surgery has been reported (MIMVS) by American Heart Association and referred to a collection of new techniques. All of these new techniques aiming to reduce surgical trauma by minimizing surgical incision, modified perfusion methods and use of new instruments . Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Minimally Invasive Mitral Valve Surgery
- What is being tested?
- mitral valve replacement through full sternotomy approach. and mitral valve replacement through right mini thoracotomy approach.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 1 Apr 2023
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with isolated rheumatic mitral valve disease in need for mitral valve replacement.
Who cannot join
- Redo mitral valve replacement.
- Emergency mitral valve replacement (non-rheumatic cases).
- Patients who have combined other valve diseases e.g. (severe Aortic Regurgitation).
- Patients need Tricuspid valve repair or replacement.
- Severely calcified mitral valve disease (mitral annular calcification).
Trial locations and contacts
1 site in 1 country.
khaled m abdelaal, professor contact
About this study
The term minimally invasive mitral valve surgery has been reported (MIMVS) by American Heart Association and referred to a collection of new techniques. All of these new techniques aiming to reduce surgical trauma by minimizing surgical incision, modified perfusion methods and use of new instruments . The right anterior mini-thoracotomy is the most common approach, next to it the lower mini-sternotomy approach, then the parasternal incision or the left posterior thoracotomy approach .
Technically MIMVS is more complex, requires a special learning curve and associated with higher Incidence of neurological events, aortic dissection, groin complications and infection despite all these benefits . MIVS also has controversies among cardiac surgeons, because it makes the exposure worse and requires a more complex surgery, which may lead to a less satisfying effect
- Conditions
- Minimally Invasive Mitral Valve Surgery
- Being tested
- mitral valve replacement through full sternotomy approach., mitral valve replacement through right mini thoracotomy approach.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitral valve replacement through full sternotomy approach.Procedure or surgery
compare between Minimally Invasive Mitral Valve Replacement and Conventional Approach
mitral valve replacement through right mini thoracotomy approach.Procedure or surgery
compare between Minimally Invasive Mitral Valve Replacement and Conventional Approach
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | patients who will undergo mitral valve replacement through full sternotomy approach Receives: Procedure: mitral valve replacement through full sternotomy approach. |
| Group B | Active comparator | patients who will undergo mitral valve replacement through right mini thoracotomy approach Receives: Procedure: mitral valve replacement through right mini thoracotomy approach. |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative pain
pain score
Measured: immediately post operative
total hospital stay in days
days in hospital included ICU stay and ward stay
Measured: maximum 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Minimally Invasive Mitral Valve SurgeryStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, abdelhamed alaaeldin ali, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504109
- Sponsor's protocol ID
- Soh-Med-22-08-12
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Falk V, Cheng DC, Martin J, Diegeler A, Folliguet TA, Nifong LW, Perier P, Raanani E, Smith JM, Seeburger J. Minimally invasive versus open mitral valve surgery: a consensus statement of the international society of minimally invasive coronary surgery (ISMICS) 2010. Innovations (Phila). 2011 Mar;6(2):66-76. doi: 10.1097/IMI.0b013e318216be5c.
PubMed 22437890Vollroth M, Seeburger J, Garbade J, Borger MA, Misfeld M, Mohr FW. Conversion rate and contraindications for minimally invasive mitral valve surgery. Ann Cardiothorac Surg. 2013 Nov;2(6):853-4. doi: 10.3978/j.issn.2225-319X.2013.10.15. No abstract available.
PubMed 24349996Joshi P, Doshi C, Vinchurkar M, Thosani R, Sagar P, Mahajan V. Minimally invasive combined aortic and mitral valve replacement. Heart Lung Circ. 2011 Apr;20(4):231-3. doi: 10.1016/j.hlc.2010.10.072. Epub 2010 Dec 10.
PubMed 21146456Schmitto JD, Mokashi SA, Cohn LH. Minimally-invasive valve surgery. J Am Coll Cardiol. 2010 Aug 3;56(6):455-62. doi: 10.1016/j.jacc.2010.03.053.
PubMed 20670754
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Mitral Valve Replacement Versus Conventional Approach: Comparison of Early Postoperative Outcomes.
- ClinicalTrials.gov ID
- NCT05504109
- Acronym / sponsor ID
- Soh-Med-22-08-12
- Conditions
- Minimally Invasive Mitral Valve Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 17 Aug 2022 (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.
The term minimally invasive mitral valve surgery has been reported (MIMVS) by American Heart Association and referred to a collection of new techniques. All of these new techniques aiming to reduce surgical trauma by minimizing surgical incision, modified perfusion methods and use of new instruments . The right anterior mini-thoracotomy is the most common approach, next to it the lower mini-sternotomy approach, then the parasternal incision or the left posterior thoracotomy approach .
Technically MIMVS is more complex, requires a special learning curve and associated with higher Incidence of neurological events, aortic dissection, groin complications and infection despite all these benefits . MIVS also has controversies among cardiac surgeons, because it makes the exposure worse and requires a more complex surgery, which may lead to a less satisfying effect
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: mitral valve replacement through full sternotomy approach.patients who will undergo mitral valve replacement through full sternotomy approach |
| Group B | Active comparator | Procedure: mitral valve replacement through right mini thoracotomy approach.patients who will undergo mitral valve replacement through right mini thoracotomy approach |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with isolated rheumatic mitral valve disease in need for mitral valve replacement.
Key exclusion criteria (5 listed)
- Redo mitral valve replacement.
- Emergency mitral valve replacement (non-rheumatic cases).
- Patients who have combined other valve diseases e.g. (severe Aortic Regurgitation).
- Patients need Tricuspid valve repair or replacement.
- Severely calcified mitral valve disease (mitral annular calcification).
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 |
|---|---|---|
| mitral valve replacement through full sternotomy approach.compare between Minimally Invasive Mitral Valve Replacement and Conventional Approach | Procedure or surgery | Group A |
| mitral valve replacement through right mini thoracotomy approach.compare between Minimally Invasive Mitral Valve Replacement and Conventional Approach | Procedure or surgery | Group B |
Primary outcome
post-operative pain
Time frame: immediately post operative
pain score
total hospital stay in days
Time frame: maximum 7 days
days in hospital included ICU stay and ward stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Background: PubMed 22437890Falk V, Cheng DC, Martin J, Diegeler A, Folliguet TA, Nifong LW, Perier P, Raanani E, Smith JM, Seeburger J. Minimally invasive versus open mitral valve surgery: a consensus statement of the international society of minimally invasive coronary surgery (ISMICS) 2010. Innovations (Phila). 2011 Mar;6(2):66-76. doi: 10.1097/IMI.0b013e318216be5c.
- Background: PubMed 24349996Vollroth M, Seeburger J, Garbade J, Borger MA, Misfeld M, Mohr FW. Conversion rate and contraindications for minimally invasive mitral valve surgery. Ann Cardiothorac Surg. 2013 Nov;2(6):853-4. doi: 10.3978/j.issn.2225-319X.2013.10.15. No abstract available.
- Background: PubMed 21146456Joshi P, Doshi C, Vinchurkar M, Thosani R, Sagar P, Mahajan V. Minimally invasive combined aortic and mitral valve replacement. Heart Lung Circ. 2011 Apr;20(4):231-3. doi: 10.1016/j.hlc.2010.10.072. Epub 2010 Dec 10.
- Background: PubMed 20670754Schmitto JD, Mokashi SA, Cohn LH. Minimally-invasive valve surgery. J Am Coll Cardiol. 2010 Aug 3;56(6):455-62. doi: 10.1016/j.jacc.2010.03.053.
- Individual participant dataSharing planned: Yes
Related trials for Minimally Invasive Mitral Valve Surgery
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Heart Valve Diseases or Prosthesis, Aortic Valve Stenosis
Recruiting
High Versus Low Dose Serratus Anterior Plane Block After Minimally Invasive Valve Surgery.
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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.
khaled m abdelaal, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mitral valve replacement through full sternotomy approach. and mitral valve replacement through right mini thoracotomy approach. in people with Minimally Invasive Mitral Valve Surgery, run by Sohag University at 1 site in Egypt.
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 5 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 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Abdelhamed A haridi, assistant lecture (01000565186, abdelhameed.abdelrehem@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative pain (time frame: immediately post operative). The study lists 2 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 NCT05504109, which also lists 4 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 17 Aug 2022.