Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06589063
Acronym
LOW-TAVR
Enrollment
1350
Registered
2024-09-19
Start date
2024-03-01
Completion date
2037-12-31
Last updated
2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Flow, Low Gradient Aortic Stenosis

Keywords

aortic stenosis, transcatheter aortic valve replacement, clinical outcomes, interventional cardiology

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 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.

Interventions

DEVICETranscatheter aortic valve replacement

Transcatheter aortic valve replacement with implantation of new-generation balloon-expandable or self-expandable bioprostheses

Sponsors

University of Salerno
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Composite of all-cause death and hospitalization for worsening heart failure1 yearDeath due to cardiac or non-cardiac cause and new hospitalization for worsening heart failure

Countries

Italy

Contacts

CONTACTGennaro Galasso, MD, PhD
ggalasso@unisa.it3497441225
CONTACTAngelo Silverio, MD, PhD
asilverio@unisa.it3286924815

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026