A Feasibility Study to Assess Safety and Efficacy of the Transapical and Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients with Symptomatic Severe Aortic Stenosis (AS) (CA-0001)/ Symptomatic Severe Aortic Regurgitation (AR) (CA-0002)

A Feasibility Study to Assess Safety and Efficacy of the Transapical and Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients with Symptomatic Severe Aortic Stenosis (AS) (CA-0001)/ Symptomatic Severe Aortic Regurgitation (AR) (CA-0002) - JenaValve AS/AR Feasibility Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46960

Enrollment

Registered

2016-01-20

Start date

2016-02-29

Completion date

Unknown

Last updated

2025-09-01

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

Conditions

leaking heart valve narrow heart valve

Interventions

Minimally invasive procedure: transcatheter aortic valve implantation (TAVI). Also known as transcatheter aortic valve replacement (TAVR).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult patients with symptomatic severe aortic stenosis or symptomatic severe aortic regurgitation who are at high risk for surgical aortic valve replacement

Exclusion criteria

Exclusion criteria: Congenital uni- or bicuspid aortic valve morphology, previous prosthetic aortic valve implant, mitral regurgitation greater than moderate

Design outcomes

Primary

Measure	Time frame
Thirty (30)-day post-index procedure all-cause mortality (adjudicated).	—

Secondary

Measure	Time frame
Study endpoints are defined according to the standardized endpoint definitions for transcatheter aortic valve implantation as outlined in The Valve Academic Research Consortium-2 consensus document (i.e. VARC-2).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)