NCT06589063

Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis

Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis: the Multicenter LOW-TAVR Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,350 (estimated)
• Sponsor: University of Salerno · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

LOW-TAVR is a real-world, retrospective and prospective, multicenter Italian registry aimed at evaluating the characteristics and clinical outcomes of patients with severe low flow, low gradient aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) and, in particular: * risk factors * gender differences * comorbidities * pharmacological treatment * TAVR procedural characteristics * periprocedural and in-hospital complications * clinical outcome at 30-day, 1-year, 2-year and 5-year follow-up

Detailed description

LOW-TAVR is a real-world, retrospective and prospective, multicenter Italian registry aimed at evaluating the characteristics and clinical outcomes of patients with severe low flow, low gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR). The register aims to include at least 1350 patients diagnosed with LFLG-AS undergoing TAVR at the participating centres. The inclusion criteria are: * LFLG-AS diagnosis according to current European Society of Cardiology guidelines * Age 18 years or older * Written informed consent The exclusion criteria are: * LFLG-AS pseudo-severe or non-confirmed severe aortic stenosis * LFLG-AS referred for medical treatment or undergoing surgery Clinical outcome is evaluated at a 30-day, 1-year, 2-year, and 5-year follow-up. The primary endpoint of interest of the registry is the assessment of the incidence of the composite of all-cause mortality and hospitalization for heart failure at one year. The secondary endpoints are the assessment of: * periprocedural TAVR complications: complete atrioventricular block, stroke, acute myocardial infarction, acute aortic insufficiency, cardiogenic shock, acute pulmonary edema, cardiac tamponade, aortic rupture; * adverse events during hospitalization: major and minor bleeding, major and minor vascular complications, definitive pacemaker implantation, cardiogenic shock, myocardial infarction, stroke, and death; * adverse events at 30 days, one year, two years, and five years: all-cause mortality, hospitalizations for heart failure, cardiovascular mortality, myocardial infarction, stroke, major and minor bleedings.

Conditions

• Low Flow, Low Gradient Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Transcatheter aortic valve replacement	Transcatheter aortic valve replacement with implantation of new-generation balloon-expandable or self-expandable bioprostheses

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-09-01
• Completion: 2037-12-31
• First posted: 2024-09-19
• Last updated: 2026-04-07

Locations

1 site across 1 country: Italy