An observational study in Aortic Stenosis, sponsored by Second Xiangya Hospital of Central South University. Status unknown at 1 site in China. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-24.
Sponsored by Second Xiangya Hospital of Central South University · Observational
The CLEVER-TAVR cohort (Cerebral Lesion and Neurocognitive Status Changes after Transcatheter Aortic Valve Replacement) is a multicenter observational cohort study. The investigators will screen consecutive patients ≥65 years of age before TAVR and enroll those that complete the procedure successfully. The investigators will assess the neurocognitive function using multiple tests with Reliable Change Index before TAVR and 7, 30, 90, 180 and 360 days after TAVR. The primary endpoint will be major adverse cardiovascular and cerebral events(MACCE, defined according to the Valve Academic Research Consortium-2 data dictionary) at 1 year.
Study Design The CLEVER-TAVR cohort (Cerebral Lesion and Neurocognitive Status Changes after Transcatheter Aortic Valve Replacement) is a multicenter prospective observational study. Patients with aortic stenosis who successfully undergo TAVR procedure from January 2021 to December 2021 will be enrolled in this study according to the inclusion criteria. Preoperative cognitive function, DW-MRI evaluation and baseline data will be recorded. All patients should be followed up for 1 year, including telephone follow-up once a month to record the main end-point events, and clinic follow-up at 30, 90, 180, 360 days after TAVR. Laboratory examination, electrocardiogram, color Doppler ultrasound and other examinations will be collected and recorded. The changes of cognitive function and brain imaging (DW-MRI) will be evaluated before discharge(7 days), 30, 90, 180, 360 days after procedure. The primary endpoint will be major adverse cardiovascular and cerebral events(MACCE), including all-cause death, stroke, acute kidney injury, myocardial infarction, bleeding complications, vascular complications, permanent pacemaker implantation, conduction block and arrhythmia, valve related complications. The postoperative valve function, life quality and other complications related to TAVR will also be recorded.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Second Xiangya Hospital of Central South University is the lead sponsor of 82 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with aortic stenosis who successfully undergo TAVR procedure in 8 centers of China.
Patients voluntarily participated and signed informed consent;
Exclusion Criteria:
Emergency procedure;
Severe cognitive impairment (MMSE \< 15), or years of education \< 6 years;
Unstable condition (intractable angina pectoris, acute heart failure) or patients can not complete MRI examination or cognitive assessment;
For analysis in Bicuspid aortic valve population.
Procedure: TAVR
Transcatheter aortic valve replacement
major adverse cardiovascular and cerebral events
Defined as VARC-2, major adverse cardiovascular and cerebral events(MACCE), including all-cause death, stroke, acute kidney injury, myocardial infarction, bleeding complications, vascular complications, permanent pacemaker implantation, conduction block and arrhythmia, valve related complications.
Time frame: 1 year.
Cognitive Decline.
Cognitive Decline is defined as Mini-mental State Examination(MMSE) score decreased by more than 3 points. The MMSE is a 30-point test, the lower the score, the worse the severity (24-30: No cognitive impairment, 18-23: mild Cognitive impairment, 0-17: severe cognitive impairment).
Time frame: 1 year.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Second Xiangya Hospital of Central South University