Cerebral Lesion and Neurocognitive Status Changes After TAVR

NCT ID: NCT04678934

Last Updated: 2020-12-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-12-31

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.

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.

Conditions

Aortic Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Bicuspid aortic valve subgroup

For analysis in Bicuspid aortic valve population.

TAVR

Intervention Type: PROCEDURE

Transcatheter aortic valve replacement

Interventions

TAVR

Transcatheter aortic valve replacement

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

Xiangtan Central Hospital

OTHER

Sponsor Role: collaborator

ZhuZhou Central Hospital

OTHER

Sponsor Role: collaborator

The First People's Hospital of Changde City

OTHER

Sponsor Role: collaborator

Xiangya Changde Hospital

UNKNOWN

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Shenghua Zhou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shenghua Zhou

Role: PRINCIPAL_INVESTIGATOR

Second xiangya Hospital

Locations

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Countries

China

Central Contacts

Shenghua Zhou

Role: CONTACT

zhoushenghua@csu.edu.cn

+8673185292012

Zhenfei Fang

Role: CONTACT

fangzhenfei@csu.edu.cn

+8613308487909

Other Identifiers

CLEVERTAVR202011-01

Identifier Type: -

Identifier Source: org_study_id