Rheumatic Heart Disease With ValvulitisNCT06696560
Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries
A study testing Minimal Invasive Approaches in Aortic surgeries. in people with Rheumatic Heart Disease With Valvulitis, run by Yahia Abd almonem Sayed.
Trial summary
To compare intraoperative and immediate postoperative outcomes of mini-sternotomy versus mini-thoracotomy as less invasive techniques in patients with isolated aortic valvular and subvalvular disease requiring surgery according to inclusion criteria. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Heart Disease With Valvulitis
- What is being tested?
- Minimal Invasive Approaches in Aortic surgeries.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2024to 30 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with isolated Aortic valve and subvalvular disease.
- sexes included with acceptance of patients to participate in this study and approval of Ethical Committee.
Who cannot join
- Patients ages who less than 16 yrs and more than 60yrs.
- Emergent open heart surgery.
- Patients with current Infective endocarditis.
- Patients with chest deformity pectus excavatum or carinatum due to difficult access.
- The patient refused to sign the informed consent to participate in the research.
- Patients with Aortic root abscess or Aortic dilatation at root or ascending parts.
About this study
To compare intraoperative and immediate postoperative outcomes of mini-sternotomy versus mini-thoracotomy as less invasive techniques in patients with isolated aortic valvular and subvalvular disease requiring surgery according to inclusion criteria.
Read the detailed description
- It has been demonstrated that minimally invasive aortic valve replacement (MIAVR) approaches are safe and effective for the treatment of aortic valve diseases. To date, the main advantage of these approaches is represented by the reduced surgical trauma, with a subsequent reduced complication rate and faster recovery. This makes such approaches an appealing choice also for frail patients [obese, aged, chronic obstructive pulmonary disease (COPD)(1).
- Minimally invasive aortic valve replacement (MIAVR) has been increasingly accepted in the surgical community as a potential alternative to conventional sternotomy, with advantages of reduced trauma, improved cosmotic and reduced hospitalization(2).
- The Mini sternotomy (MS) approach represents the most common technique used for Minimally invasive AVR. The MS approach is achieved through 6 to 10cm midline vertical skin incision, performing a partial J sternotomy at the third to fifth intercostal space (3). MIAVR via right mini thoracotomy (RT) is performed through five to seven cm skin incision placed at the level of the second intercostal space without rib resection. After sacrificing the right internal thoracic artery(4).
- Despite these excellent results, there have been an increasing number of cases performed via minimally invasive aortic valve replacement (MIAVR). This approach has now become an established alternative to FS in order to reduce the "invasiveness" of the surgical procedure, while maintaining the same efficacy, quality and safety of a conventional approach (5).
- Conditions
- Rheumatic Heart Disease With Valvulitis
- Being tested
- Minimal Invasive Approaches in Aortic surgeries.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal Invasive Approaches in Aortic surgeries.Other
Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries
| Study group | Role | What they receive |
|---|---|---|
| Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries. | Other | Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries. Receives: Other: Minimal Invasive Approaches in Aortic surgeries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries.
To reduce operation duration,so less hospital stay period. Echocardiography assessment intraoperative and postoperative.
Measured: Within 2 years .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start15 Nov 2024 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic Heart Disease With ValvulitisStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yahia Abd almonem Sayed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yahia Abd almonem Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696560
- Sponsor's protocol ID
- AssiutU 1
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries
- ClinicalTrials.gov ID
- NCT06696560
- Acronym / sponsor ID
- AssiutU 1
- Conditions
- Rheumatic Heart Disease With Valvulitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Yahia Abd almonem SayedUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 20 Nov 2024 (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.
To compare intraoperative and immediate postoperative outcomes of mini-sternotomy versus mini-thoracotomy as less invasive techniques in patients with isolated aortic valvular and subvalvular disease requiring surgery according to inclusion criteria.
Detailed description
- It has been demonstrated that minimally invasive aortic valve replacement (MIAVR) approaches are safe and effective for the treatment of aortic valve diseases. To date, the main advantage of these approaches is represented by the reduced surgical trauma, with a subsequent reduced complication rate and faster recovery. This makes such approaches an appealing choice also for frail patients [obese, aged, chronic obstructive pulmonary disease (COPD)(1).
- Minimally invasive aortic valve replacement (MIAVR) has been increasingly accepted in the surgical community as a potential alternative to conventional sternotomy, with advantages of reduced trauma, improved cosmotic and reduced hospitalization(2).
- The Mini sternotomy (MS) approach represents the most common technique used for Minimally invasive AVR. The MS approach is achieved through 6 to 10cm midline vertical skin incision, performing a partial J sternotomy at the third to fifth intercostal space (3). MIAVR via right mini thoracotomy (RT) is performed through five to seven cm skin incision placed at the level of the second intercostal space without rib resection. After sacrificing the right internal thoracic artery(4).
- Despite these excellent results, there have been an increasing number of cases performed via minimally invasive aortic valve replacement (MIAVR). This approach has now become an established alternative to FS in order to reduce the "invasiveness" of the surgical procedure, while maintaining the same efficacy, quality and safety of a conventional approach (5).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries. | Other | Other: Minimal Invasive Approaches in Aortic surgeries.Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with isolated Aortic valve and subvalvular disease.
- sexes included with acceptance of patients to participate in this study and approval of Ethical Committee.
Key exclusion criteria (6 listed)
- Patients ages who less than 16 yrs and more than 60yrs.
- Emergent open heart surgery.
- Patients with current Infective endocarditis.
- Patients with chest deformity pectus excavatum or carinatum due to difficult access.
- The patient refused to sign the informed consent to participate 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 |
|---|---|---|
| Minimal Invasive Approaches in Aortic surgeries.Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries | Other | Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries. |
Primary outcome
Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries.
Time frame: Within 2 years .
To reduce operation duration,so less hospital stay period. Echocardiography assessment intraoperative and postoperative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal Invasive Approaches in Aortic surgeries. in people with Rheumatic Heart Disease With Valvulitis, run by Yahia Abd almonem Sayed.
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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 20 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries. (time frame: Within 2 years .). 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 20 Nov 2024.