Aortic Valve Stenosis
Conditions
Brief summary
To confirm the safety and performance of the Medtronic Engager™ Transcatheter Aortic Valve Implantation System via direct aortic approach.
Detailed description
To confirm the safety and performance of the Medtronic Engager™ Transcatheter Aortic Valve Implantation System via direct aortic approach in patients with symptomatic severe aortic valve stenosis at high or extreme risk for surgical aortic valve replacement for which treatment via direct aortic access is preferred.
Interventions
DEVICEEngager™ aortic valve
Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
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
* Severe aortic stenosis as defined by Doppler echocardiography: aortic valve area ≤ 0.8 cm2 (or AVA index ≤ 0.5 cm2/m2), or mean gradient ≥ 40 mmHg, or max velocity ≥ 4m/s * NYHA Functional Class II or greater; * Logistic EuroSCORE I ≥ 20%, or comorbidity judged by the heart team to pose an absolute or relative contraindication for conventional aortic valve replacement; * Non-calcified ascending aortic site ≥ 50 mm from the aortic valve basal plane; * Age ≥ 18 years; * The patient has been informed of the nature of the study and has consented to participate, authorizing the collection and release of his/her medical information by signing a consent form (Patient Informed Consent Form). Patient should understand the implications of participating in the study and should be legally competent to provide informed consent.
Exclusion criteria
* Unicuspid or bicuspid aortic valve; * Echocardiographic evidence of intracardiac mass, thrombus, or vegetation; * Left ventricular ejection fraction \< 25%; * Left ventricular outflow obstruction, such as Hypertrophic Obstructive Cardiomyopathy and severe septal hypertrophy; * Mitral or tricuspid regurgitation greater than 2+ by angiography or moderate by echocardiography; * Patients with life expectancy less than 12 months due to an underlying non-cardiac co-morbid disease; * Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, Nitinol or contrast medium that cannot be adequately controlled with pre-medication; * Sepsis or acute endocarditis; * Blood dyscrasia such as acute anemia, leucopenia, or thrombocytopenia; bleeding diathesis, or coagulopathy; * Renal insufficiency assessed by creatinine clearance \< 20 ml/min and/or end-stage renal disease requiring chronic dialysis; * Active peptic ulcer or GI bleeding within 3 months from the planned index procedure; * Untreated clinically significant coronary artery disease requiring revascularization; * Cardiogenic shock, suspected cardiogenic shock, or hemodynamic instability requiring inotropic support or mechanical heart assistance; * Significant aortic disease, including abdominal and thoracic aortic aneurysm, defined as maximal luminal diameter of 5 cm or greater; * Need for emergency surgery, cardiac or non-cardiac; * History of myocardial infarction in the last 6 weeks; * History of TIA or CVA in the last 6 months; * Therapeutic invasive cardiac procedure, with the exception of BAV, performed within 30 days of the planned date of valve implantation, or 6 months in the case of drug-eluting stents; * Pre-existing prosthetic heart valve or prosthetic ring in any position; * Patent RIMA or pre-existing patent RIMA graft at direct aortic access site and/or trajectory; * Patient refuses a blood transfusion; * Pregnant or breastfeeding women; * Patient is currently enrolled in another investigational device or drug trial that may influence the outcome of this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Delivery System Success | Within 30 days of implant procedure | Acute delivery system success, defined as bioprosthesis deployed in anatomically correct position and freedom from delivery system related complications at the end of the procedure. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Device Success According to VARC2 | 30 days post-procedure | Device success is a composite of: Absence of 30-day in-hospital death Correct position of the device within the aortic annular region Intended performance of the bioprosthesis (no patient-prosthesis mismatch, mean aortic gradient \<20 mmHg or peak velocity \<3 m/s at discharge, and no moderate or severe prosthetic valve regurgitation) |
| Composite 30-day Safety Endpoint According to VARC2 | 30-days post-procedure | Percentage of Participants with any of the following Safety Events within 30-days post-procedure: All-cause mortality All stroke Life-threatening bleeding Acute kidney injury (stage 2-3) Coronary artery obstruction requiring intervention Major vascular complication Valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVR) |
| Composite Clinical Efficacy Endpoint After 30 Days According to VARC2 | 30-days post-procedure | Percentage of Participants with any of the following Safety Events after 30-days post-procedure: All-cause mortality All stroke Hospitalization for valve-related symptoms or worsening congestive heart failure |
Countries
Czechia, Germany, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Engager™ Aortic Valve Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
Engager™ aortic valve: Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 6 |
Baseline characteristics
| Characteristic | Engager™ Aortic Valve |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 20 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 80.6 years STANDARD_DEVIATION 3.4 |
| Peripheral vascular disease No peripheral vascular disease | 10 participants |
| Peripheral vascular disease Peripheral vascular disease | 10 participants |
| Region of Enrollment Czech Republic | 3 participants |
| Region of Enrollment Germany | 14 participants |
| Region of Enrollment United Kingdom | 3 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
| STS Risk of Mortality | 5.9 % STANDARD_DEVIATION 4.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 20 |
| serious Total, serious adverse events | 20 / 20 |
Outcome results
Primary
Acute Delivery System Success
Acute delivery system success, defined as bioprosthesis deployed in anatomically correct position and freedom from delivery system related complications at the end of the procedure.
Time frame: Within 30 days of implant procedure
Population: Analysis for this endpoint includes subjects with an implant attempt.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Engager™ Aortic Valve | Acute Delivery System Success | 95.0 percentage of participants |
Other Pre-specified
Composite 30-day Safety Endpoint According to VARC2
Percentage of Participants with any of the following Safety Events within 30-days post-procedure: All-cause mortality All stroke Life-threatening bleeding Acute kidney injury (stage 2-3) Coronary artery obstruction requiring intervention Major vascular complication Valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVR)
Time frame: 30-days post-procedure
Population: Analysis for this endpoint includes subjects with an implant attempt.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Engager™ Aortic Valve | Composite 30-day Safety Endpoint According to VARC2 | 25.0 percentage of participants |
Other Pre-specified
Composite Clinical Efficacy Endpoint After 30 Days According to VARC2
Percentage of Participants with any of the following Safety Events after 30-days post-procedure: All-cause mortality All stroke Hospitalization for valve-related symptoms or worsening congestive heart failure
Time frame: 30-days post-procedure
Population: Analysis for this endpoint includes subjects at risk (or alive and in study) at 30 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Engager™ Aortic Valve | Composite Clinical Efficacy Endpoint After 30 Days According to VARC2 | 94.4 percentage of participants |
Other Pre-specified
Device Success According to VARC2
Device success is a composite of: Absence of 30-day in-hospital death Correct position of the device within the aortic annular region Intended performance of the bioprosthesis (no patient-prosthesis mismatch, mean aortic gradient \<20 mmHg or peak velocity \<3 m/s at discharge, and no moderate or severe prosthetic valve regurgitation)
Time frame: 30 days post-procedure
Population: Analysis for this endpoint includes subjects with an implant attempt.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Engager™ Aortic Valve | Device Success According to VARC2 | 15.0 percentage of participants |