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

NCT06589063 | Recruiting DMC

• 1 other identifier: 13202409
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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

Conditions

Low Flow, Low Gradient Aortic Stenosis

Keywords

aortic stenosis; transcatheter aortic valve replacement; clinical outcomes; interventional cardiology

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Transcatheter aortic valve replacement DEVICE

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

Also known as: TAVI, TAVR, Transcatheter aortic valve implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• LFLG-AS diagnosis according to current European Society of Cardiology guidelines
• Age 18 years or older
• Written informed consent

You may not qualify if:

• LFLG-AS pseudo-severe or non-confirmed severe aortic stenosis
• LFLG-AS referred for medical treatment or undergoing surgery

Sponsors & Collaborators

• University of Salerno: lead

Study Sites (1)

University of Salerno

Salerno, Italy, 84131, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Central Study Contacts

Gennaro Galasso, MD, PhD

CONTACT

3497441225; ggalasso@unisa.it

Angelo Silverio, MD, PhD

CONTACT

3286924815; asilverio@unisa.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion (Estimated): December 31, 2037
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)