Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589063
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Transcatheter Aortic Valve Replacement in Severe Low Flow Low Gradient Aortic Stenosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Transcatheter Aortic Valve Replacement in Severe Low Flow Low Gradient Aortic Stenosis the Multicenter LOW-TAVR Registry
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOW-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
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 1500 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
The register aims to include at least 1500 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None