TAVI in LOW RISK in the REAL WORLD

NCT07605780 | Completed

• 1 other identifier: NP1073
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to assess all-cause mortality, the occurrence of stroke, or rehospitalization for cardiovascular causes in low-risk "all-comers" patients following percutaneous aortic valve replacement

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (3)

• All-cause mortality

  Up to 12 months

• Occurrence of stroke

  Up to 12 months

• Rehospitalization for cardiovascular causes

  Up to 12 months

Secondary Outcomes (5)

• Occurrence of major or minor bleeding

  Up to 12 months

• Implantation of a permanent pacemaker

  Up to 12 months

• Development of paroxysmal or permanent atrial fibrillation

  Up to 12 months

• Infectious causes requiring prolonged monitoring in the hospital

  Up to 12 months

• Presence of significant paravalvular or intravalvular regurgitation

  Up to 12 months

Study Arms (1)

Patients with symptomatic severe aortic valve stenosis

Consecutive patients with symptomatic severe aortic valve stenosis and low surgical risk-defined as an STS-PROM score (Society of Thoracic Surgeons Predicted Risk of Mortality for isolated SAVR) of less than 4% and no major organ damage-who were treated with TAVI.

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

Consecutive patients with symptomatic severe aortic valve stenosis and low surgical risk-defined as an STS-PROM score (Society of Thoracic Surgeons Predicted Risk of Mortality for isolated SAVR) of less than 4% and no major organ damage-who were treated with TAVI.

You may qualify if:

• Patients aged 18 years or older
• Patients with severe symptomatic aortic valve stenosis undergoing TAVI.
• Patients considered to be at low surgical risk, defined as an STS-PROM (Society of Thoracic Surgeons Predicted Risk of Mortality for isolated SAVR) score of less than 4% and no major organ damage.

You may not qualify if:

• Patients who required emergency aortic valve replacement for any reason
• Need for conversion to SAVR during the procedure
• Patients who refused to consent to participate in the study

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead
• Fondazione Poliambulanza Istituto Ospedaliero: collaborator

Study Sites (1)

Fondazione Poliambulanza Istituto Ospedaliero, Unità Emodinamica

Brescia, BS, 25124, Italy

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: May 26, 2026
• Study Start: December 13, 2024
• Primary Completion: August 24, 2025
• Study Completion: August 24, 2025
• Last Updated: May 26, 2026

Record last verified: 2026-04

Locations

IT (1)