Severe Aortic Valve Stenosis Clinical Trial
Official title:
Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China
NCT number | NCT04988243 |
Other study ID # | DB001 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2021 |
Est. completion date | August 2028 |
Verified date | August 2021 |
Source | CCRF Inc., Beijing, China |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study was to observe the safety and effectiveness of transcatheter aortic valve replacement in patients with aortic valve stenosis in a real-world clinical practice environment.
Status | Not yet recruiting |
Enrollment | 320 |
Est. completion date | August 2028 |
Est. primary completion date | August 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Severe aortic valve stenosis, defined as follows: 1. Symptomatic patients: - The mean differential pressure measured by echocardiography = 40mm Hg - Or peak aortic ejection = 4.0 m / S - Or aortic valve area = 1.0cm ²( Or AVA index = 0.6 cm2 / m2) 2. Asymptomatic patients: - Severe aortic stenosis and aortic valve area = 1.0cm ²( 6 cm2 / m2) with aortic ejection peak value = 5.0 M / s or mean pressure difference measured by --echocardiography = 60 mm Hg; - Or aortic valve area = 1.0cm ²( Or AVA index = 0.6 cm2 / m2), combined with aortic ejection peak = 4.0 m / s or average differential pressure measured by echocardiography = 40 mm Hg, combined with limited exercise tolerance test, abnormal blood pressure response or arrhythmia; - Or aortic valve area = 1.0cm ²( Or AVA index = 0.6 cm2 / m2), combined with aortic ejection peak = 4.0 m / s or average differential pressure measured by echocardiography = 40 mm Hg, combined with LVEF < 50% 2. Subjects who plan (or have) to use the transcatheter aortic valve replacement system for percutaneous aortic valve replacement 3. The patients agreed to join the study, voluntarily signed the informed consent and completed the follow-up; 4. Be able to contact the subjects or their legal guardians / relatives; 5. The medical record records the subjects who have died and can't get any contact information of the subjects( (for dead cases only) Note: for dead subjects, they must meet 1, 2 and 5 at the same time before they can be included in the group. Exclusion Criteria: 1. Contraindications to any artificial biological valve implantation; 2. Any known allergies or contraindications; - Aspirin or heparin and bivalirudin; - Tigrelol and clopidogrel; - Nickel titanium alloy; - Contrast medium; 3. The patient is currently participating in drug or device research; 4. The patient is pregnant or lactating; 5. Aortic annulus diameter < 17 mm or > 32 mm; 6. The diameter of approach vessel was less than 5.0mm; 7. The investigator believes that the patient is not suitable to participate in this study or complete the follow-up specified in the protocol; |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
CCRF Inc., Beijing, China | Hangzhou Qiming Medical Instrument Co., Ltd |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary end point: the incidence of all-cause death 12 months after operation | After subjects completed aortic valve replacement surgery, whether prospectively or retrospectively, all-cause mortality at 12 months after operation was collected according to the time node of subjects' enrollment | 12 months after aortic valve replacement | |
Secondary | The compound incidence of death, surgery, severe stroke, life-threatening bleeding, serious vascular complications and acute renal failure (within 30 days after operation); | The compound incidence of death, surgery, severe stroke, life-threatening bleeding, serious vascular complications and acute renal failure (within 30 days after operation); | Within 30 days after aortic valve replacement | |
Secondary | The implantation rate of permanent pacemaker within 30 days; | The implantation rate of permanent pacemaker within 30 days; | Within 30 days after aortic valve replacement | |
Secondary | All stroke (disabled or not disabled) within 12 months and 2, 3, 4 and 5 years | All stroke (disabled or not disabled) within 12 months and 2, 3, 4 and 5 years; | 12 months and within 2, 3, 4 and 5 years | |
Secondary | the incidence of life-threatening bleeding within 12 months and 2, 3, 4 and 5 years; | the incidence of life-threatening bleeding within 12 months and 2, 3, 4 and 5 years; | 12 months and within 2, 3, 4 and 5 years | |
Secondary | The incidence of reoperation due to dysfunction of prosthetic valve within 12 months and 2,3,4,5 years; | The incidence of reoperation due to dysfunction of prosthetic valve within 12 months and 2,3,4,5 years; | 12 months and within 2, 3, 4 and 5 years | |
Secondary | The incidence of readmission due to symptoms and signs of aortic valve disease within 12 months and 2,3,4,5 years; | The incidence of readmission due to symptoms and signs of aortic valve disease within 12 months and 2,3,4,5 years; | 12 months and within 2, 3, 4 and 5 years | |
Secondary | The incidence of prosthetic valve dysfunction at 12 months (moderate or severe stenosis or reflux by ultrasonography); | The incidence of prosthetic valve dysfunction at 12 months (moderate or severe stenosis or reflux by ultrasonography); | 12 months and within 2, 3, 4 and 5 years | |
Secondary | The incidence of thrombus in clinical and subclinical prosthetic heart valves at 12 months; | The incidence of thrombus in clinical and subclinical prosthetic heart valves at 12 months; | 12 months after aortic valve replacement |
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