NCT01762124

Study of the Native Outflow Tract Transcatheter Pulmonary Valve (TPV)

Native Outflow Tract Transcatheter Pulmonary Valve Research Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Medtronic Heart Valves · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this early feasibility study is to determine how a new transcatheter pulmonary valve will move and perform once implanted in the right ventricular outflow tract.

Detailed description

Medtronic, Inc. is in the process of developing a novel transcatheter device option for patients with congenital heart disease, without right ventricle-to-pulmonary artery conduits, called the Native Outflow Tract Transcatheter Pulmonary Valve. Given limitations in the animal model to confirm device boundary conditions, this feasibility study is proposed to characterize that information as well as evaluate safety, procedural feasibility and performance data to be used for future development of the device.

Conditions

• Congenital Heart Disease
• Tetralogy of Fallot

Interventions

Type	Name	Description
DEVICE	Native Outflow Tract TPV	Transcatheter placement of a pulmonary valve

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-05-01
• Completion: 2020-07-01
• First posted: 2013-01-07
• Last updated: 2020-08-07

Locations

3 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study