Severe, Symptomatic Aortic Stenosis Clinical Trial
Official title:
Medtronic CoreValve™ Evolut™ PRO System China Clinical Study
| Verified date | May 2023 |
| Source | Medtronic Cardiovascular |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Interventional study to evaluate the safety and efficacy of the Medtronic CoreValve™ Evolut™ PRO System when used by China implanting centers in Chinese patients with severe symptomatic aortic stenosis (AS) who are at high risk for Surgical Aortic Valve Replacement (SAVR).
| Status | Active, not recruiting |
| Enrollment | 58 |
| Est. completion date | November 28, 2028 |
| Est. primary completion date | March 17, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years and older |
| Eligibility | Inclusion Criteria: 1. Aortic valve area (AVA) < 1.0 cm2 (or indexed AVA <0.6 cm2/m2) OR mean gradient > 40 mmHg, OR max aortic velocity > 4.0 m/sec 2. High risk for SAVR defined as STS-PROM score = 8% AND = 15%, OR documented Heart Team agreement of high risk for AVR due to frailty or comorbidities 3. Symptoms of aortic stenosis and NYHA = II Exclusion Criteria: 1. Age is less than 65 years old 2. Non-calcified aortic valve 3. Bicuspid aortic valve with no raphe or 2 raphes (Sievers classification type 0 or type 2) 4. Ascending aortic diameter > 4.5 cm |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Anzhen Hospital, Capital Medical University | Beijing | Beijing |
| China | Chinese PLA General Hospital, Chinese PLA Medical School | Beijing | Beijing |
| China | West China Hospital of Sichuan University | Chengdu | Sichuan |
| China | The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic Cardiovascular |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Event rates of TAVI-related complications | Rate of the following TAVI-related complications: change to surgery need for cardiopulmonary mechanical assistance coronary occlusion or obstruction annular rupture or dissection ventricular perforation mitral valve damage prosthetic valve displacement, migration, or embolism acute kidney injury (up to 7 days post procedure) |
6 months, 1 year, 2 years, 3 years, 4 years and 5 years | |
| Other | All-cause mortality | Percentage of participants with all-cause mortality, cardiovascular and non-cardiovascular mortality | 6 months, 1 year, 2 years, 3 years, 4 years and 5 years | |
| Other | All stroke | Incidence of stroke (disabling and non-disabling) | 6 months, 1 year, 2 years, 3 years, 4 years and 5 years | |
| Other | Myocardial infarction | Incidence of periprocedural MI and spontaneous MI | 30days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years | |
| Other | Incidence of life-threatening bleeding | Incidence of life-threatening bleeding: Fatal bleeding (BARC type 5) OR Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR Overt source of bleeding with drop in hemoglobin =5 g/dL or whole blood or packed red blood cells (RBCs) transfusion =4 units* (BARC type 3b) |
30days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years | |
| Other | New AV-Conduction disturbances | Incidence of left bundle branch block and Right bundle branch block | 30 days | |
| Other | Incidence of prosthetic valve endocarditis | Incidence of prosthetic valve endocarditis: Fulfillment of the following Duke criteria for definite endocarditis Evidence of abscess, paravalvular leak, pus, or vegetation confirmed as secondary to infection by histological or bacteriological studies during a re-operation Findings of abscess, pus, or vegetation involving the CoreValve™ Evolut™ PRO at autopsy |
30days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years | |
| Other | Incidence of Prosthetic valve thrombosis | Incidence of Prosthetic valve thrombosis: Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. *Valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve related should not be reported as valve thrombosis. |
30days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years | |
| Other | Incidence of valve-related dysfunction | Incidence of valve-related dysfunction defined as moderate or severe prosthetic valve stenosis, or moderate or severe prosthetic regurgitation (per VARC II) | 1 year, 2 years, 3 years, 4 years and 5 years | |
| Other | Incidence of Valve-related dysfunction requiring repeat procedure | Incidence of Valve-related dysfunction requiring repeat procedure | 30days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years | |
| Other | Valve hemodynamic performance metric - Mean aortic gradient | • Mean aortic gradient | 1 year, 2 years, 3 years, 4 years and 5 years | |
| Other | Valve hemodynamic performance metric - Effective orifice area | • Effective orifice area | 1 year, 2 years, 3 years, 4 years and 5 years | |
| Other | Valve hemodynamic performance metric - Degree of aortic regurgitation (transvalvular, paravalvular, total) | • Degree of aortic regurgitation (transvalvular, paravalvular, total) | 1 year, 2 years, 3 years, 4 years and 5 years | |
| Other | Incidence of New York Heart Association (NYHA) functional classification | Incidence of New York Heart Association (NYHA) functional classification | 6 months, 1 year, 2 years, 3 years, 4 years and 5 years | |
| Other | Quality of Life change from baseline EuroQol-5 Dimension [EQ-5D] | QoL: EQ-5D | 30 days, 1 year | |
| Primary | All-cause mortality | Percentage of participants with all-cause mortality, cardiovascular and non-cardiovascular mortality | 30 days | |
| Primary | Percentage (%) of evaluable echocardiograms with moderate or severe aortic regurgitation | Percentage (%) of evaluable echocardiograms with moderate or severe aortic regurgitation by transthoracic echocardiography (TTE) | 30 days | |
| Secondary | Incidence of an VARC II combined composite | Incidence of an VARC II combined composite includes the following components: All-cause mortality All stroke (disabling and non-disabling) Life-threatening bleeding Acute kidney injury: stage 2 or 3 (including renal replacement therapy) Coronary artery obstruction requiring intervention Major vascular complication Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR) |
30 days | |
| Secondary | Event rates of the individual components of the VARC II composite | Event rate of the individual components listed in the outcome 3 | 30 days | |
| Secondary | New permanent pacemaker rate | New permanent pacemaker rate | 30 days | |
| Secondary | Device success rate | Device success rate: Percentage of participants with absence of procedural mortality, AND Percentage of participants with correct positioning of a single prosthetic heart valve into the proper anatomical location, AND Percentage of participants with intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity <3m/sec), AND absence of moderate or severe prosthetic valve regurgitation |
Between 24 hours and 7 days post procedure | |
| Secondary | Valve performance parameter - Mean aortic gradient | • Mean aortic gradient | 30 days | |
| Secondary | Valve performance parameter - Effective orifice area | • Effective orifice area | 30 days | |
| Secondary | Valve performance parameter -Degree of aortic regurgitation (transvalvular, paravalvular, total) | • Degree of aortic regurgitation (transvalvular, paravalvular, total) | 30 days |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01675596 -
The SOLACE-AU Clinical Trial
|
N/A |