Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis (LOW-TAVR)

University of Salerno

Status

Enrolling

Conditions

Low Flow, Low Gradient Aortic Stenosis

Treatments

Device: Transcatheter aortic valve replacement

Study type

Observational

Funder types

Other

Identifiers

NCT06589063

13202409

Details and patient eligibility

About

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

Full 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 1,500 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.

Enrollment

1,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria