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Cerebral Lesion and Neurocognitive Status Changes After TAVR (CLEVER-TAVR)

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ClinicalTrials.gov Identifier: NCT04678934
Recruitment Status : Not yet recruiting
First Posted : December 22, 2020
Last Update Posted : December 24, 2020
Sponsor:
Collaborators:
Xiangya Hospital of Central South University
The Third Xiangya Hospital of Central South University
Xiangtan Central Hospital
ZhuZhou Central Hospital
The First People's Hospital of Changde City
Xiangya Changde Hospital
West China Hospital
Information provided by (Responsible Party):
Shenghua Zhou, Second Xiangya Hospital of Central South University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Aortic Stenosis Procedure: TAVR

Detailed Description:
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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Cerebral Lesion and Neurocognitive Status Changes After Transcatheter Aortic Valve Replacement：A Prospective Multicenter Observational Cohort Study.
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Bicuspid aortic valve subgroup
For analysis in Bicuspid aortic valve population.
 Procedure: TAVR
Transcatheter aortic valve replacement


Outcome Measures
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Primary Outcome Measures :
  1. major adverse cardiovascular and cerebral events [ Time Frame: 1 year. ]
    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.


Secondary Outcome Measures :
  1. Cognitive Decline. [ Time Frame: 1 year. ]
    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).


Biospecimen Retention:   Samples With DNA
Blood, stool

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with aortic stenosis who successfully undergo TAVR procedure in 8 centers of China.
Criteria

Inclusion Criteria:

  • Patients voluntarily participated and signed informed consent;

    • Patients with severe aortic stenosis undergo TAVR after assessment by the Heart Team; [Definition of severe aortic stenosis: mean aortic pressure gradient (MPG) ≥ 40 mmHg, aortic valve area (AVA) ≤ 1.0 cm2 and maximal aortic velocity (Vmax) ≥ 4 m / s.] ③ Age ≥ 65 years old.

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;

        • TAVR operation failed or transferred to surgery for SAVR due to serious complications; ⑤ Speech disorders, or mental disorders, or severe physical disorders (MRS ≥ 3); ⑥ Patients with complicated congenital heart disease, HCM, surgery valve replacement or combined valvular disease; ⑦ Patients with life expectancy less than 12 months.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04678934


Contacts
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Contact: Shenghua Zhou +8673185292012 zhoushenghua@csu.edu.cn
Contact: Zhenfei Fang +8613308487909 fangzhenfei@csu.edu.cn

Locations
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China, Hunan
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
Sponsors and Collaborators
Second Xiangya Hospital of Central South University
Xiangya Hospital of Central South University
The Third Xiangya Hospital of Central South University
Xiangtan Central Hospital
ZhuZhou Central Hospital
The First People's Hospital of Changde City
Xiangya Changde Hospital
West China Hospital
Investigators
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Principal Investigator: Shenghua Zhou Second xiangya Hospital
More Information
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Responsible Party: Shenghua Zhou, Professor, Second Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT04678934    
Other Study ID Numbers: CLEVERTAVR202011-01
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction