Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases
Conditions
Keywords
Aortic Valve Disease, Aortic Valve Replacement, Transcatheter, Transfemoral, Aortic Stenosis
Brief summary
The objective of this study is to evaluate feasibility, safety and effectiveness of the first generation transfemoral JenaValve Pericardial TAVR System (formerly named JenaValve TAVI Plus System- Transfemoral) in an elderly patient population with severe aortic stenosis who are at high risk for surgical aortic valve replacement.
Detailed description
The study is designed as a prospective, multi-center trial conducted at 2 centers in Germany enrolling up to 12 subjects. Each patient will be followed for 2 years. The last patient's follow-up will end in February 2016. It is planned that the study will end in June 2016. Study endpoints are defined in accordance with the Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium (VARC-2). These endpoint definitions combine the expertise of surgeons, interventionalists, medical cardiologists, clinical trial and other specialists and allow for comparison of different trials concerning effectiveness and safety in TAVI.
Interventions
The JenaValve Pericardial TAVI system is intended for use in subjects with symptomatic severe aortic stenosis who are at high risk for surgical aortic valve replacement.
Sponsors
JenaValve Technology, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with severe native aortic valve stenosis * NYHA functional class II or higher * Increased risk for surgical aortic valve replacement * Comply with post-operative follow-up visits and requirements
Exclusion criteria
* Combined aortic valve disease with severe aortic insufficiency * Presence of moderate mitral insufficiency or previous mitral prosthesis * Severe pulmonary hypertension * Congenital uni- or bicuspid aortic valve * Endocarditis or active infection * Life expectancy \< 12 months * Need for emergency surgery for any reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Mortality | 30 days | 30-day mortality of procedure is defined as all deaths within 30 days after implantation of the JenaValve Plus Prosthesis irrespective of the underlying cause of death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate and standard deviation of VARC-2 Individual Safety Endpoints | Index Procedure and Immediate Post-operative | * Myocardial Infarction * Stroke * Major Bleeding * Acute Kidney Injury * Vascular Complications * Conduction Disturbances and Arrhythmias * TAVR-related Complications |
Other
| Measure | Time frame | Description |
|---|---|---|
| Device Success | Index Procedure and Immediate Post-operative | Absence of procedural mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve |
| Clinical Outcomes through 2-year follow-up - Hemodynamic Performance | Prior to discharge, at 3, 6, 12 and 24 months | Improvement in mean gradient and effective orifice area compared to baseline and over time as assessed by Echocardiogram |
| Clinical Outcomes through 2-year follow-up - NYHA Functional Classification | Prior to discharge, at 3, 6, 12 and 24 months | Number of patients with improvement over time as compared to baseline |
Countries
Germany
Outcome results
None listed