Clinical Trial: JenaValve Pericardial TAVR Aortic Regurgitation Study

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Safety and Efficacy of the Transapical and Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Regurgitation (AR)

Brief Summary: The purpose of this research study is to collect information about a new treatment for severe aortic regurgitation, which affects the aortic valve in the heart. Aortic regurgitation is a condition where the heart's aortic valve does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery. A 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, which is intended to help treat severe aortic regurgitation. The JenaValve replacement valve is placed inside the aortic valve by using the JenaValve delivery system. The JenaValve replacement valve may be implanted in one of two ways: (1) transapical - where the valve is implanted through the chest wall, and (2) transfemoral - where the valve is implanted through an artery in the groin. The choice of which implant method will be used is decided by the doctor.

Detailed Summary:
Sponsor: JenaValve Technology, Inc.

Current Primary Outcome: All-Cause Mortality Rate at 30 Days [ Time Frame: 30 days ]

All-cause mortality rate at 30 days


Original Primary Outcome:

Current Secondary Outcome:

  • Event rate of VARC-2 Individual Safety Endpoints [ Time Frame: 2 years ]

    Event rate of VARC-2 Individual Safety Endpoints procedurally to 30 days, 6 months, 1 year, and 2 years for the following:

    • All-cause mortality
    • Myocardial infarction
    • Neurological Complications - All-cause stroke and transient ischemic attack (TIA)
    • Bleeding Complications
    • Acute kidney injury (AKIN classification within 7 days post-index procedure)
    • Vascular Complications (Major, minor, closure device failure)
    • Conduction Disturbances and Arrhythmias
    • TAVR-related complications
  • Clinical Outcomes through 2 year follow up - KCCQ [ Time Frame: 2 years ]

    Number of patients with improvement vs. baseline in symptoms measured by:

    - Improvement vs. baseline in Quality of Life, per Kansas City Cardiomyopathy Questionnaire (KCCQ greater than 10 from baseline)

  • Clinical Outcomes through 2 year follow up - NYHA Class [ Time Frame: 2 years ]

    Number of patients with improvement vs. baseline in symptoms measured by:

    - NYHA Class greater than 1 over baseline, or NYHA Class less than III or IV

  • Clinical Outcomes through 2 year follow up - 6MWT [ Time Frame: 2 years ]

    Number of patients with improvement vs. baseline in symptoms measured by:

    - Improvement vs. baseline in functional status using six minute walk test (6MWT) improvement greater than 50 feet from baseline



Original Secondary Outcome:

Information By: JenaValve Technology, Inc.

Dates:
Date Received: March 18, 2016
Date Started: June 2016
Date Completion: July 2019
Last Updated: May 2, 2016
Last Verified: May 2016