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Optimized strategy for bicuspid valve-related dilation: prospective, single center, randomized controlled study

Optimized strategy for bicuspid valve-related dilation: prospective, single center, randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103113
Enrollment
Unknown
Registered
2025-05-26
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bicuspid aortic valve associated aortopathy

Interventions

Control group (patients undergoing only aortic valve replacement):Only aortic valve replacement, without concurrent ascending/aortic root replacement.
treatment group (patients requiring aortic valve replacement who also undergo concurrent ascending/aortic root replacement):Patients requiring aortic valve replacement who also undergo concurrent asc

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The subject (or legal guardian) understands the trial requirements and treatment procedures, signs a written informed consent form, and purchases medical insurance; 2. Age >=18 years; 3.Chest aortic CTA shows the ascending/aortic root diameter between 40-45mm; 4. Preoperative TTE and intraoperative exploration confirm the patient has BAV; 5. Patients requiring other cardiac surgeries, including AVR.

Exclusion criteria

Exclusion criteria: 1. Patients with acute type A aortic dissection; 2. History of previous aortic root surgery; 3. Combined with other complex congenital diseases (such as Turner syndrome, Marfan syndrome, etc.); 4. Severe comorbidities (end-stage organ failure, malignant tumors, etc.) resulting in a life expectancy of < 1 year; 5. Refusal of surgery by the patient and/or family.

Design outcomes

Primary

MeasureTime frame
reintervention rate;All-cause mortality;

Secondary

MeasureTime frame
Aortic complications;

Countries

China

Contacts

Public ContactZhenghua Xiao

West China Hospital of Sichuan University

xiaozhenghua@wchscu.cn+86 13880775126

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026