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Clinical Trials in Italy / NCT06589063
Recruiting Observational

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

NCT06589063 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Salerno
Phase
Observational
Started
2024-03-01
Last updated
2026-04-07

Condition(s) studied

Low Flow, Low Gradient Aortic Stenosis

Investigational drug(s) / intervention(s)

Transcatheter aortic valve replacement

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

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • Composite of all-cause death and hospitalization for worsening heart failure — 1 year
    Death due to cardiac or non-cardiac cause and new hospitalization for worsening heart failure

Trial sites (1)

FacilityCityRegionStatus
University of Salerno Salerno Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06589063 on ClinicalTrials.gov ↗ ← All trials in Italy