NCT05737264
Recruiting
N/A
Safety and Effectiveness of Transcatheter Treatment of Severe Native Aortic Regurgitation With Self-Expandable Valve Implantation: a Multicenter, Observational,Cohort Study(SENSE-AR)
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 site in 1 country76 target enrollmentDecember 1, 2022
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Transcatheter Aortic Valve Replacement
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Disabling stroke
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Disabling stroke
Time Frame: 12 months
Stroke that results in a disabled state
Rehospitalization for heart failure
Time Frame: 12 months
Rehospitalization for heart failure
all-cause mortality
Time Frame: 12 months
Death caused by any reason
Secondary Outcomes
- Perioperative complications(up to 1 week)
- New permanent pacemaker implantation(PPI)(up to 1 week)
- New complete left bundle branch block(CLBBB)(up to 1 week)
- NYHA class Ill or IV(12 months)
- Device success(intraoperative)
- Valve-related dysfunction(12 months)
Study Sites (1)
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