CompletedNot Applicable

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 range18 Years – 80 Years

SexALL

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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.
✕. Patients with extensive aortic root destruction because of aortic root infection.

What they're measuring

Number of subjects who die

Timeframe: 30 days

Trial details

NCT IDNCT03604913

SponsorAssiut University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-27

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