Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases, Ventricular Outflow Obstruction
Conditions
Keywords
Valvular Heart Disease, Critical/Severe Aortic Stenosis, High risk symptomatic patients
Brief summary
To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.
Detailed description
This study will examine the use of a TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. This 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.
Interventions
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
Sponsors
JenaValve Technology, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with severe degenerative native aortic stenosis (AS). * Patient at high risk for open surgical valve replacement * Patient symptomatic according to NYHA functional class II or higher
Exclusion criteria
* Congenital uni- or bicuspid aortic valve morphology * Previous prosthetic aortic valve (bioprosthesis or mechanical) implant * Endocarditis or other active infection * Need for urgent or emergent TAVR procedure for any reason * Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Mortality | 30 Day | All-cause mortality rate at 30 Day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All Stroke/TIA | 30 Day | Neurological Complications |
| Major Bleeding | 30 Day | Life threatening or major bleeding |
| Major Vascular Complication | 30 Day | Major vascular and bleeding complications |
| Conduction Disturbance and Arrhythmias | 30 Day | Conduction system injury (defect), including AV block, which may require a permanent pacemaker |
| Myocardial Infarction | 30 Day | Peri-procedural and spontaneous myocardial infarction |
| Coronary Obstruction Requiring Intervention | 30 Day | Coronary obstruction post-implant requiring intervention |
| Endocarditis | 30 Day | Bacterial endocarditis |
| Conversion to Surgical Aortic Valve Replacement (SAVR) | 30 Day | Number of patients who underwent conversion to open sternotomy during the TAVR procedure secondary to any procedure-related complications |
| THV Malpositioning | 30 Day | Number of patients who experienced: Migration: After initial correct positioning, the valve prosthesis moves upwards or downwards, within the aortic annulus from its initial position, with or without consequences Embolization: The valve prosthesis moves during or after deployment such that it loses contact with the aortic annulus Ectopic Valve Deployment: Permanent deployment of the valve prosthesis in a location other than the aortic root |
| Acute Kidney Injury (AKI) | 30 Day | Number of patients who were diagnosed with AKI Stage 2 or 3: AKI Stage 2: Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR urine output \<0.5 mL/kg/h for \>12 but \<24 h AKI Stage 3: Increase in serum creatinine to ≥300% (\>3 × increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR urine output \<0.3 ml/kg/h for ≥24 h OR anuria for ≥12 h |
Countries
Germany, Netherlands, New Zealand, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system. | 68 |
| Total | 68 |
Baseline characteristics
| Characteristic | Transcatheter Aortic Valve Replacement (TAVR) | — |
|---|---|---|
| Age, Continuous | 83 years STANDARD_DEVIATION 5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 44 Participants | — |
| Sex: Female, Male Male | 24 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 68 |
| other Total, other adverse events | 23 / 68 |
| serious Total, serious adverse events | 39 / 68 |
Outcome results
Primary
All-Cause Mortality
All-cause mortality rate at 30 Day
Time frame: 30 Day
Population: Enrolled
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | All-Cause Mortality | 2 Participants |
Secondary
Acute Kidney Injury (AKI)
Number of patients who were diagnosed with AKI Stage 2 or 3: AKI Stage 2: Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR urine output \<0.5 mL/kg/h for \>12 but \<24 h AKI Stage 3: Increase in serum creatinine to ≥300% (\>3 × increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR urine output \<0.3 ml/kg/h for ≥24 h OR anuria for ≥12 h
Time frame: 30 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Acute Kidney Injury (AKI) | 0 Participants |
Secondary
All Stroke/TIA
Neurological Complications
Time frame: 30 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | All Stroke/TIA | 6 Participants |
Secondary
Conduction Disturbance and Arrhythmias
Conduction system injury (defect), including AV block, which may require a permanent pacemaker
Time frame: 30 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Conduction Disturbance and Arrhythmias | 10 Participants |
Secondary
Conversion to Surgical Aortic Valve Replacement (SAVR)
Number of patients who underwent conversion to open sternotomy during the TAVR procedure secondary to any procedure-related complications
Time frame: 30 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Conversion to Surgical Aortic Valve Replacement (SAVR) | 1 Participants |
Secondary
Coronary Obstruction Requiring Intervention
Coronary obstruction post-implant requiring intervention
Time frame: 30 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Coronary Obstruction Requiring Intervention | 0 Participants |
Secondary
Endocarditis
Bacterial endocarditis
Time frame: 30 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Endocarditis | 0 Participants |
Secondary
Major Bleeding
Life threatening or major bleeding
Time frame: 30 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Major Bleeding | 4 Participants |
Secondary
Major Vascular Complication
Major vascular and bleeding complications
Time frame: 30 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Major Vascular Complication | 5 Participants |
Secondary
Myocardial Infarction
Peri-procedural and spontaneous myocardial infarction
Time frame: 30 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Myocardial Infarction | 1 Participants |
Secondary
THV Malpositioning
Number of patients who experienced: Migration: After initial correct positioning, the valve prosthesis moves upwards or downwards, within the aortic annulus from its initial position, with or without consequences Embolization: The valve prosthesis moves during or after deployment such that it loses contact with the aortic annulus Ectopic Valve Deployment: Permanent deployment of the valve prosthesis in a location other than the aortic root
Time frame: 30 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | THV Malpositioning | 3 Participants |