TAVR in Adults With Pure Severe Aortic Regurgitation (SENSE-AR)

Sun Yat-sen University

Status: Enrolling

Conditions: Transcatheter Aortic Valve Replacement; Aortic Regurgitation

Study type: Observational

Funder types: Other

Identifiers

NCT05737264

SYSKY-2022-518-01

Details and patient eligibility

About

The study aimed to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in patients with severe native valve aortic insufficiency. It is a multicentre, observational cohort study. The primary endpoint consisted of a composite of all-cause death, disabling stroke, or rehospitalization for heart failure at 12 months postoperatively. According to previous research results and opinions of expert groups, the sample size was expected to be 76 cases.

Enrollment: 76 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 60 years;
• Patients with severe aortic regurgitation (> grade 3) diagnosed by transthoracic echocardiography should meet any of the following conditions for semi-quantitative assessment of the degree of aortic regurgitation and any condition for quantitative assessment of the degree of aortic regurgitation: (1) semi-quantitative assessment of the degree of aortic regurgitation: aortic regurgitation bundle width/left ventricular outflow tract diameter ≥ 65%; or aortic regurgitation neck width > 6 mm; or full-diastolic blood flow reflux in the proximal abdominal aorta; (2) quantitative assessment of the degree of aortic regurgitation: aortic regurgitation volume ≥ 60 ml/beat; or aortic regurgitation fraction ≥ 50%; or effective regurgitation orifice area ≥ 0.3 cm2
• TAVR has been performed;
• Patients can understand and voluntarily participate in this clinical study, sign informed consent, and adhere to clinical follow-up.

Exclusion criteria

• History of aortic valve replacement;
• Combined with moderate-severe mitral regurgitation and moderate aortic stenosis;
• Acute endocarditis or other acute cardiac inflammation;
• Allergic or contraindicated to related drugs (aspirin, clopidogrel, warfarin, contrast agent);
• Other conditions judged by the investigator as not suitable for the study

Trial design

76 participants in 1 patient group

TAVR group

Description:

The group that undergoes transcatheter aortic valve replacement