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

NCT ID: NCT06589063

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2037-12-31

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.

Conditions

Low Flow, Low Gradient Aortic Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Transcatheter aortic valve replacement

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

Intervention Type: DEVICE

Other Intervention Names

TAVI; TAVR; Transcatheter aortic valve implantation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Salerno

OTHER

Sponsor Role: lead

Responsible Party

Gennaro Galasso

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Salerno

Salerno, Italy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Gennaro Galasso, MD, PhD

Role: CONTACT

ggalasso@unisa.it

3497441225

Angelo Silverio, MD, PhD

Role: CONTACT

asilverio@unisa.it

3286924815

Facility Contacts

Gennaro Galasso, MD, PhD

Role: primary

ggalasso@unisa.it

+393497441225

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

13202409

Identifier Type: -

Identifier Source: org_study_id