Mitral Valve DiseaseNCT03195595
Minimal Invasive Mitral Valve Replacement Versus Conventional Median Sternotomy Approach
An observational study of Mitral Valve Disease, run by Assiut University at 1 site in Egypt.
Trial summary
This is retrospective study that will be done in Cardiothoracic surgery department in Assuit university hospitals for one year duration aiming to compare minimal invasive technique to conventional median sternotomy for mitral valve surgery regarding early postoperative outcomes and pain Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Disease
- What is being tested?
- mitral valve replacement and conventional mitral valve replacement
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 31 Oct 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It includes groups of population above age of 18 with symptomatic mitral valve disease indicated for valve surgery
Who may be able to join
- Symptomatic patients with mitral valve disease indicated for valve surgery
Who cannot join
- Double valve disease or other valve disease
- Mitral or aortic valve disease associated with ischemic heart disease
- Mitral or aortic valve disease associated with congenital heart disease
- Patients subjected to prior heart surgery
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospitals
Asyut
Elhussein abdelmottaleb, master, 00201003873076, husseinmoh24@gmail.com
About this study
This is retrospective study that will be done in Cardiothoracic surgery department in Assuit university hospitals for one year duration aiming to compare minimal invasive technique to conventional median sternotomy for mitral valve surgery regarding early postoperative outcomes and pain
Read the detailed description
This is retrospective study that will be done in Cardiothoracic surgery department in Assuit university hospitals for one year duration and the study tools will be:
Part I (Demographic data):
- Age, Gender, Weight, Height ,Smoke history
Part II (Preoperative data):
- Medical history, Clinical assessment, Preoperative investigation
Part III (Intraoperative data):
- Surgical time, and Ischemic time
Part IV (Postoperative data):
- Early ambulation, ICU stay, length of ventilation, using of analgesic drugs, post op bleeding, deaths
- Conditions
- Mitral Valve Disease
- Being tested
- mitral valve replacement, conventional mitral valve replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitral valve replacementDevice
early postoperative outcome regarding pain in minimal invasive technique
conventional mitral valve replacementDevice
early postoperative outcome regarding pain in conventional median sternotomy
| Study group | Role | What they receive |
|---|---|---|
| mitral valve replacement | patients whom underwent Mitral valve replacement through minimal invasive incision Receives: Device: mitral valve replacement; Device: conventional mitral valve replacement | |
| conventional mitral valve replacement | patients whom underwent Mitral valve replacement through conventional sternotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating of postoperative pain by using numerical rating scales (NRS)
its a score result from gathered information from the patient
Measured: one year
Secondary outcomes (1)
Evaluating early postoperative outcome
e.g., bleeding
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start1 Apr 2020
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve DiseaseStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elhussein Mohamed Abdelmottaleb, Assiut University
- Investigators
- mohamed A nady, lecturer, Study director, Assuit university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195595
- Sponsor's protocol ID
- 17100176
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2017
- Last updated
- 12 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Invasive Mitral Valve Replacement Versus Conventional Median Sternotomy Approach
- ClinicalTrials.gov ID
- NCT03195595
- Acronym / sponsor ID
- 17100176
- Conditions
- Mitral Valve Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 22 Jun 2017 (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.
This is retrospective study that will be done in Cardiothoracic surgery department in Assuit university hospitals for one year duration aiming to compare minimal invasive technique to conventional median sternotomy for mitral valve surgery regarding early postoperative outcomes and pain
Detailed description
This is retrospective study that will be done in Cardiothoracic surgery department in Assuit university hospitals for one year duration and the study tools will be:
Part I (Demographic data):
- Age, Gender, Weight, Height ,Smoke history
Part II (Preoperative data):
- Medical history, Clinical assessment, Preoperative investigation
Part III (Intraoperative data):
- Surgical time, and Ischemic time
Part IV (Postoperative data):
- Early ambulation, ICU stay, length of ventilation, using of analgesic drugs, post op bleeding, deaths
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mitral valve replacement | – | Device: mitral valve replacement, Device: conventional mitral valve replacementpatients whom underwent Mitral valve replacement through minimal invasive incision |
| conventional mitral valve replacement | – | –patients whom underwent Mitral valve replacement through conventional sternotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It includes groups of population above age of 18 with symptomatic mitral valve disease indicated for valve surgery
Key inclusion criteria (1 listed)
- Symptomatic patients with mitral valve disease indicated for valve surgery
Key exclusion criteria (4 listed)
- Double valve disease or other valve disease
- Mitral or aortic valve disease associated with ischemic heart disease
- Mitral or aortic valve disease associated with congenital heart disease
- Patients subjected to prior heart surgery
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 replacementearly postoperative outcome regarding pain in minimal invasive technique | Device | mitral valve replacement |
| conventional mitral valve replacementearly postoperative outcome regarding pain in conventional median sternotomy | Device | mitral valve replacement |
Primary outcome
Evaluating of postoperative pain by using numerical rating scales (NRS)
Time frame: one year
its a score result from gathered information from the patient
1 secondary outcome
Evaluating early postoperative outcome
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- 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.
mohamed A nady, lecturer study director
Assuit university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Disease, run by Assiut 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 4 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 12 Jun 2020. 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 Elhussein abdelmottaleb, master (00201003873076, husseinmoh24@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating of postoperative pain by using numerical rating scales (NRS) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2020.