A feasibility study to assess the safety and efficacy of JenaValve for patients with severe aortic regurgitation (AR).

A Feasibility Study to Assess Safety and Efficacy of the Transapical and Transfemoral JenaValve Pericardial TAVR (Transcatheter Aortic Valve Replacement) System in the Treatment of Patients with Symptomatic Severe Aortic Regurgitation (AR)

Status

Suspended

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000718448

Enrollment

Registered

2016-05-30

Start date

2016-04-19

Completion date

2016-04-19

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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’s main pumping chamber – the left ventricle. Symptoms of aortic regurgitation may include fatigue and shortness of breath. In New Zealand the options available for treating severe aortic regurgitation include surgical aortic valve replacement or treatment with medications. This investigational device has been designed to enable the treatment of aortic regurgitation in a TAVI procedure. Your doctors have determined that you need a new aortic heart valve. TAVI is offered to those patients who are at high risk for undergoing open heart surgery to replace the aortic valve.. It has been determined however that you may meet the criteria to have your valve replaced with the JenaValve Pericardial TAVR System as part of this research study. 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.

Interventions

This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. The JenaValve Pericardial TAVR System will be examined in this clinical study for aortic valve replacement. The TAVR procedure is performed by a heart surgeon and a cardiologist. The TAVR device may be implanted transapical, which is placed through your chest wall, or transfemoral, which is placed though an artery in your groin. The choice of which which approach is used is at the clinical discretion of the study physicians.. The TAVR procedure typically takes 1-2 hours to complete. The JenaValve TAVR device, once implanted, is designed to remain permanently in place.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patient with severe aortic regurgitation (AR) assessed by echocardiography 2. Patient at high risk for open surgical valve replacement 3. Patient symptomatic according to NYHA functional class II or higher.

Exclusion criteria

1. Congenital uni- or bicuspid aortic valve morphology 2. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant 3. Endocarditis or other active infection 4. Need for urgent or emergent TAVR procedure for any reason 5. Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device

Outcome results