Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcatheter aortic valve replacement.
- Who it may be relevant to
- Registry conditions: Low Flow, Low Gradient Aortic Stenosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis: the Multicenter LOW-TAVR Registry
Overview
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
- Device Transcatheter aortic valve replacement
Transcatheter aortic valve replacement with implantation of new-generation balloon-expandable or self-expandable bioprostheses
Primary outcome measures
- Composite of all-cause death and hospitalization for worsening heart failure [Time frame: 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- University of Salerno — Salerno
Publications
- Ferruzzi GJ, Bellino M, Silverio A, Saia F, Bruno AG, Boragine P, Buono A, De Rosa ML, Cancro FP, Porto I, Crimi G, Calabro P, Moscarella E, Ielasi A, Montonati C, De Carlo M, Sticchi A, Lanni F, Di Muro FM, Maiellaro F, Calchera IF, Boccuzzi G, Sorropago A, Scudiero F, Attisano T, Citro R, Granata G, De Luca G, Musumeci G, Galasso G; LOW-TAVR Investigators. Balloon-Expandable Versus Self-Expandin PMID 42132173
Identifiers
NCT: NCT06589063 · 13202409