Clinical trial NCT06589063: Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis
Official title: Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis: the Multicenter LOW-TAVR Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Flow, Low Gradient Aortic Stenosis
Keywords: aortic stenosis
transcatheter aortic valve replacement
clinical outcomes
interventional cardiology
Lead sponsor: University of Salerno
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe low flow, low gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR)

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* LFLG-AS diagnosis according to current European Society of Cardiology guidelines
* Age 18 years or older
* Written informed consent

Exclusion Criteria:

* LFLG-AS pseudo-severe or non-confirmed severe aortic stenosis
* LFLG-AS referred for medical treatment or undergoing surgery

Primary outcomes:
measure: Composite of all-cause death and hospitalization for worsening heart failure
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Salerno
country: Italy
facility: University of Salerno
Study officials:
References: