NCT03200574

Behavior of Valve Leaflets Following Aortic Valve Implant

Behavior of Valve Leaflets and the Incidence of Reduced Mobility Post-surgical Aortic Valve Implant

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Corcym S.r.l · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant.

Detailed description

This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant, on patients that are off anticoagulation for at least 30 days. A minimum of 75 subjects with evaluable 4D CT scans will be enrolled at approximately 11 investigational sites where the devices are commercially available. For asymptomatic subjects, PIs and subjects will be blinded from the CT imaging results and from the Core Lab findings.

Conditions

• Aortic-valve Replacement

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	4D Cardiac CT Scan	4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy
DEVICE	LivaNova Bioprothetic Aortic Valve Implant	Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.

Timeline

• Start date: 2017-12-06
• Primary completion: 2020-06-15
• Completion: 2021-02-25
• First posted: 2017-06-27
• Last updated: 2024-03-06
• Results posted: 2023-12-26

Locations

11 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study