NCT02732691

JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study

JENAVALVE ALIGN-AS TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Stenosis (AS)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: JenaValve Technology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.

Detailed description

This study will examine the use of a TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. This less invasive surgical approach called TAVR is offered to those patients who are high risk for undergoing open heart surgery to replace the aortic valve. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System.

Conditions

• Aortic Valve Stenosis
• Heart Valve Diseases
• Heart Diseases
• Cardiovascular Diseases
• Ventricular Outflow Obstruction

Interventions

Type	Name	Description
DEVICE	JenaValve Pericardial TAVR System	Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.

Timeline

• Start date: 2016-10-21
• Primary completion: 2019-05-28
• Completion: 2024-04-01
• First posted: 2016-04-11
• Last updated: 2022-11-22
• Results posted: 2022-11-22

Locations

13 sites across 4 countries: United States, Germany, Netherlands, New Zealand