Prospective Neuropsychological Evaluation of the Implementation of a Heart Valve Unit (HVU-NEURO) (HVU-NEURO)
Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis. Despite improved procedural outcomes, neurocognitive complications such as postoperative delirium (POD) and postoperative cognitive decline (POCD) remain clinically relevant.
Heart Valve Units (HVU) are specialized interdisciplinary care structures designed to improve treatment pathways and healthcare quality. However, their impact on neuropsychological outcomes has not been sufficiently investigated.
HVU-NEURO is a prospective observational cohort study evaluating neuropsychological outcomes before and after implementation of an HVU. Approximately 500 patients undergoing transcatheter valve therapy will be included.
Neurocognitive function will be assessed before intervention, at hospital discharge, and three months after intervention. POD will be assessed using the Intensive Care Delirium Screening Checklist (ICDSC). The primary objective is to evaluate the effect of HVU implementation on postoperative cognitive decline at discharge from acute hospital care.
연구 개요
상태
상세 설명
HVU-NEURO is a prospective single-center observational cohort study conducted at the Kerckhoff-Klinik Bad Nauheim, Germany. The study investigates whether implementation of a structured Heart Valve Unit (HVU) influences neuropsychological outcomes in patients undergoing transcatheter valve therapy.
Approximately 500 consecutive patients undergoing transcatheter valve therapy will be prospectively enrolled during two predefined 6-month observation periods before and after HVU implementation, separated by a 6-month run-in/blanking phase.
Neuropsychological assessments will be performed preinterventionally, at discharge from acute hospital care, and three months after intervention. Postoperative delirium (POD) will be assessed during intensive care treatment using the Intensive Care Delirium Screening Checklist (ICDSC).
The primary endpoint is postoperative cognitive decline (POCD) at discharge from acute hospital care. Secondary endpoints include POCD at three months, postoperative delirium, patient-reported postoperative neurocognitive symptoms, affective symptoms, posttraumatic stress symptoms, and instrumental activities of daily living.
The study aims to improve understanding of neuropsychological outcomes and their integration into modern structured heart valve care pathways.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Marius Butz, Phd, M.Sc.
- 전화번호: +49 6032 9965812
- 이메일: m.butz@kerckhoff-klinik.de
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Severe aortic valve stenosis
- Indication for transcatheter valve therapy according to current guideline recommendations and/or Heart-Team consensus
- Sufficient German language proficiency, as study-related tests, questionnaires, and instructions are administered in German
- Age ≥18 years
- Willingness to participate voluntarily with written informed consent
Exclusion Criteria:
- Known pregnancy at the time of study inclusion
- Life expectancy <1 year due to non-cardiac disease
- Pre-interventional psychiatric and neurological disorders (known and diagnosed dementia, depression, history of stroke or transient ischemic attack [TIA], migraine, epilepsy) with acute symptoms that may interfere with data collection
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
Non-HVU Cohort
Patients undergoing transcatheter valve therapy during the predefined 6-month observation period before implementation of the Heart Valve Unit (HVU).
|
|
HVU Implementation Cohort
Patients undergoing transcatheter valve therapy during the 6-month HVU implementation and run-in phase.
|
|
Post-HVU Cohort
Patients undergoing transcatheter valve therapy during the predefined 6-month observation period after implementation of the Heart Valve Unit (HVU).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postoperative cognitive decline (POCD) assessed by a detailed neuropsychological test battery at discharge from acute hospital care
기간: At discharge from acute hospital care (typically within 7 days after intervention)
|
Postoperative cognitive decline (POCD) will be assessed using repeated neuropsychological testing covering DSM-5-related cognitive domains and subdomains. POCD is defined as a decline of at least one standard deviation in at least 20% of assessed neurocognitive subdomains compared with baseline assessment. Learning and memory will be assessed using the Montreal Cognitive Assessment (MoCA) word list, including delayed free recall and the Memory Index Score (MIS). Complex attention will be assessed using the Trail Making Test A (TMT-A) for selective attention and the SKT-7 subtest of the Syndrom-Kurztest (SKT) for inhibitory control. Language will be assessed using the Regensburg Verbal Fluency Test (RWT), including semantic and phonemic verbal fluency. Perceptual-motor function will be assessed using the MoCA three-dimensional figure copy task. |
At discharge from acute hospital care (typically within 7 days after intervention)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postoperative cognitive decline (POCD) assessed by a detailed neuropsychological test battery at 3 months
기간: 3 months after intervention
|
Postoperative cognitive decline (POCD) will be assessed using repeated neuropsychological testing covering DSM-5-related cognitive domains and subdomains. POCD is defined as a decline of at least one standard deviation in at least 20% of assessed neurocognitive subdomains compared with baseline assessment. Learning and memory will be assessed using the Montreal Cognitive Assessment (MoCA) word list, including delayed free recall and the Memory Index Score (MIS). Complex attention will be assessed using the Trail Making Test A (TMT-A) for selective attention and the SKT-7 subtest of the Syndrom-Kurztest (SKT) for inhibitory control. Language will be assessed using the Regensburg Verbal Fluency Test (RWT), including semantic and phonemic verbal fluency. Perceptual-motor function will be assessed using the MoCA three-dimensional figure copy task. |
3 months after intervention
|
|
Postoperative Delirium
기간: During intensive care stay (up to 2 days)
|
Incidence of postoperative delirium assessed during intensive care treatment using the Intensive Care Delirium Screening Checklist (ICDSC).
|
During intensive care stay (up to 2 days)
|
|
Patient-Reported Neurocognitive Symptoms
기간: 3 months after intervention
|
Patient-reported postoperative neurocognitive symptoms assessed using the Postoperative Neurocognitive Disorder Questionnaire (PNCD-Q).
|
3 months after intervention
|
|
Postoperative Affective Symptoms
기간: 3 months after intervention
|
Patient-reported affective symptoms assessed using the Postoperative Affective Disorder Questionnaire (PAD-Q).
|
3 months after intervention
|
|
Posttraumatic Stress Symptoms
기간: 3 months after intervention
|
Posttraumatic stress symptoms assessed using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).
|
3 months after intervention
|
|
Instrumental Activities of Daily Living
기간: 3 months after intervention
|
Functional impairment assessed using Instrumental Activities of Daily Living (IADL).
|
3 months after intervention
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Matthias Renker, MD, Campus Kerckhoff, Justus-Liebig-Universität Gießen
- 수석 연구원: Marius Butz, Phd, M.Sc., Campus Kerckhoff, Justus-Liebig-Universität Gießen
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 185/25-HVU-NEURO
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .