Minimally invasive Bentall procedure for aortic root lesions
Safety and Efficacy of the Minimally Invasive Bentall Procedure Via a Small Right Intercostal Incision in Patients With Aortic Root Lesions: an Investigator-initiated, Single-center, Retrospective Cohort Study
This study is testing if a new, less invasive heart surgery for aortic root problems is safer and more effective than the traditional open-heart surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital Xi'an Jiaotong University Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT06177548 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of the minimally invasive Bentall procedure performed through a small right intercostal incision in patients with aortic root lesions. Patients treated at the First Affiliated Hospital of Xi'an Jiaotong University between January 2019 and July 2023 will be divided into two groups: those who underwent the minimally invasive approach and those who had traditional surgery via a median sternal incision. By comparing clinical outcomes between these groups, the study aims to assess the advantages of the minimally invasive technique.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with aortic root lesions who have undergone the Bentall procedure at the specified hospital during the study period.
Not a fit: Patients with previous sternotomy or aortic root surgery, or those requiring additional complex procedures, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery times and reduced complications for patients undergoing Bentall surgery.
How similar studies have performed: While minimally invasive surgical techniques have shown promise in various procedures, this specific approach to the Bentall procedure is novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - Patients who were diagnosed with aortic root lesions and treated with the Bentall procedure at the First Affiliated Hospital of Xi'an Jiaotong University from January 2019 to July 2023 will be included in this study. Exclusion Criteria: * Previous sternotomy or aortic root surgery; * Combined coronary artery disease requiring simultaneous coronary revascularization; * Combined aortic arch lesions requiring simultaneous aortic arch surgery; * Preoperative comorbidities with severe single or multiple organ failure; * Incomplete clinical information;
Where this trial is running
Xi'an, Shaanxi
- First Affiliated Hospital of Xi'an Jiantong University — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Principal investigator: Yang Yan — First Affiliated Hospital Xi'an Jiaotong University
- Study coordinator: Yan Yang
- Email: yangyan3@xjtu.edu.cn
- Phone: +86.29.85323869
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.