Aortic Valve Sparing Root Replacement Versus Bentall
Egypt122 participantsStarted 2019-02-01
Plain-language summary
This study was designed to evaluate the hypothesis that the operative and midterm results of valve-sparing aortic root replacement are equivalent to those of the Bentall.
Objective 1:
Evaluate short-term (one-to-six months) and mid-term (six-to-forty-eight months) results of aortic valve-sparing procedures.
Objective 2:
Compare the results of aortic valve-sparing procedures with the group of patients undergoing Bentall procedures during the same period.
Objective 3:
Assess outcomes of both procedures through evaluation of postoperative:
A) primary outcome measures:
1. Intraoperative or intrahospital death.
2. Reexploration for bleeding.
3. Reoperation rate.
4. Grade of aortic valve regurgitation (0-4).
B)secondary outcome measures:
1. Grade of aortic valve regurgitation (0-4).
2. Mean gradient on the aortic valve(mmHg).
3. Thromboembolism / bleeding.
4. Prosthetic/native valve endocarditis.
5. 2-year mortality
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ascending aorta or aortic root aneurysm(size more than 5 cm or 4.5 cm in Marfan syndrome).
. Ascending aorta or aortic root dissection.
. With or without aortic regurgitation
. Good condition of aortic cusps.
Exclusion criteria
. The left ventricular ejection fraction less than 40 %.
. Previous aortic valve replacement.
. Aortic stenosis.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.