NCT05536310

TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease

Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease: Patient Registry and Post-Market Clinical Follow-up Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: JenaValve Technology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).

Detailed description

Aortic stenosis (AS) is a narrowing of the aortic valve opening causing restricted blood flow from the left ventricle to the aorta and may also affect the pressure in the left atrium. Aortic regurgitation (AR) is a condition where the aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of AS and AR may include fatigue and shortness of breath. Aortic valve disease can affect both elderly and younger populations. TAVIS Registry will collect data from patients suffering from either AS or AR using a minimally invasive transcatheter aortic valve implantation procedure.

Conditions

• Aortic Valve Stenosis
• Aortic Valve Regurgitation
• Aortic Valve Stenosis With Insufficiency
• Constriction, Pathologic
• Aortic Valve Disease
• Heart Valve Diseases
• Cardiovascular Diseases in Old Age
• Ventricular Outflow Obstruction
• Aortic Stenosis, Severe

Interventions

Type	Name	Description
DEVICE	Transcatheter Aortic Valve Implantation (TAVI)	TAVI with the JenaValve Trilogy Heart Valve System

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-10-01
• Completion: 2027-10-01
• First posted: 2022-09-10
• Last updated: 2023-01-11

Locations

3 sites across 1 country: Germany

Regulatory

• FDA-regulated device study