Cerebral Lesion and Neurocognitive Status Changes After TAVR

NCT04678934 | Unknown DMC

• 1 other identifier: CLEVERTAVR202011-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year.

Secondary Outcomes (1)

• Cognitive Decline.

  1 year.

Study Arms (1)

Bicuspid aortic valve subgroup

For analysis in Bicuspid aortic valve population.

Procedure: TAVR

Interventions

TAVR PROCEDURE

Transcatheter aortic valve replacement

Bicuspid aortic valve subgroup

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with aortic stenosis who successfully undergo TAVR procedure in 8 centers of China.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead
• Xiangya Hospital of Central South University: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• Xiangtan Central Hospital: collaborator
• ZhuZhou Central Hospital: collaborator
• The First People's Hospital of Changde City: collaborator
• Xiangya Changde Hospital: collaborator
• West China Hospital: collaborator

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Shenghua Zhou

  Second xiangya Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shenghua Zhou

CONTACT

+8673185292012; zhoushenghua@csu.edu.cn

Zhenfei Fang

CONTACT

+8613308487909; fangzhenfei@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 22, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)