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

Cerebral Lesion and Neurocognitive Status Changes After Transcatheter Aortic Valve Replacement：A Prospective Multicenter Observational Cohort Study.

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 Overview

• Status: Unknown
• Conditions: Aortic Stenosis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Shenghua Zhou; Phone Number: +8673185292012; Email: zhoushenghua@csu.edu.cn
• Study Contact Backup: Name: Zhenfei Fang; Phone Number: +8613308487909; Email: fangzhenfei@csu.edu.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • The second Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bicuspid aortic valve subgroup; For analysis in Bicuspid aortic valve population.	Procedure: TAVR; Transcatheter aortic valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 year.

Collaborators and Investigators

• Sponsor: Second Xiangya Hospital of Central South University
• Collaborators: Xiangya Hospital of Central South University; West China Hospital; The Third Xiangya Hospital of Central South University; ZhuZhou Central Hospital; Xiangtan Central Hospital; Xiangya Changde Hospital; The First People's Hospital of Changde City
• Investigators: Principal Investigator: Shenghua Zhou, Second Xiangya Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (ACTUAL): December 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: CLEVERTAVR202011-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No