Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis (LOW-TAVR)

Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis: the Multicenter LOW-TAVR Registry

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

Study Overview

• Status: Recruiting
• Conditions: Low Flow, Low Gradient Aortic Stenosis
• Intervention / Treatment: Device: Transcatheter aortic valve replacement

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.

• Study Type: Observational
• Enrollment (Estimated): 1350

Contacts and Locations

• Study Contact: Name: Gennaro Galasso, MD, PhD; Phone Number: 3497441225; Email: ggalasso@unisa.it
• Study Contact Backup: Name: Angelo Silverio, MD, PhD; Phone Number: 3286924815; Email: asilverio@unisa.it

Study Locations

• Italy
  • Salerno, Italy, 84131
    • Recruiting
    • University of Salerno
    • Contact: Gennaro Galasso, MD, PhD; Phone Number: +393497441225; Email: ggalasso@unisa.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe low flow, low gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of all-cause death and hospitalization for worsening heart failure	Death due to cardiac or non-cardiac cause and new hospitalization for worsening heart failure	1 year

Collaborators and Investigators

• Sponsor: University of Salerno

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): September 1, 2025
• Study Completion (Estimated): December 31, 2037

Study Registration Dates

• First Submitted: September 5, 2024
• First Submitted That Met QC Criteria: September 5, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: aortic stenosis; clinical outcomes; interventional cardiology; transcatheter aortic valve replacement
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Surgical Procedures, Operative; Cardiovascular Surgical Procedures; Cardiac Surgical Procedures; Thoracic Surgical Procedures; Prosthesis Implantation; Heart Valve Prosthesis Implantation; Transcatheter Aortic Valve Replacement
• Other Study ID Numbers: 13202409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No