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Aortic Valve Sparing Root Replacement Versus Bentall

NCT03604913 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2025-02-19

No results posted yet for this study

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

Conditions

  • Aortic Root Aneurysm
  • Aortic Root Dissection

Interventions

PROCEDURE

Aortic valve sparing operation

Aortic valve sparing instead of replacement during aortic root replacement

PROCEDURE

Bentall operation

Aortic root replacement with replacement of aortic valve

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Mohamed A Nady, Lecturer · Assist university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2024-02-27
Completion
2024-05-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03604913 on ClinicalTrials.gov