Not provided
Not provided
Not provided
Not provided
Due to inability to recruit sufficient sample size in reasonable time frame.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcatheter Aortic Valve Replacement | Experimental | In this study, transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial TAVR System, which is intended for use in subjects with severe aortic stenosis. The JenaValve replacement valve is placed inside the aortic valve by using a delivery system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JenaValve Pericardial TAVR System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Mortality | 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate and standard deviation of VARC-2 Individual Safety Endpoints |
| Index Procedure and Immediate Post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success | 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 | Index Procedure and Immediate Post-operative |
| Clinical Outcomes through 2-year follow-up - Hemodynamic Performance |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephan Baldus, MD | University of Koln Medical Center | Principal Investigator |
| Hendrik Treede, MD | University of Hamburg Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Koln Medical Center | Cologne | 50937 | Germany | |||
| University of Hamburg Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D014694 | Ventricular Outflow Obstruction |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Improvement in mean gradient and effective orifice area compared to baseline and over time as assessed by Echocardiogram |
| Prior to discharge, at 3, 6, 12 and 24 months |
| Clinical Outcomes through 2-year follow-up - NYHA Functional Classification | Number of patients with improvement over time as compared to baseline | Prior to discharge, at 3, 6, 12 and 24 months |
| Hamburg |
| 20251 |
| Germany |