Cognitive Outcome After Surgical and Transcatheter Aortic Valve Replacement

NCT04535076 | Completed

• 1 other identifier: MC 68/2017
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Aortic valve stenosis is one of the most common types of heart disease in the aging Western population. While surgical cardiac valve replacement (SAVR) is a standard therapy for patients with aortic stenosis, catheter-assisted aortic valve implantation (TAVI) has developed as an alternative to open-heart surgery, especially for high-risk patients. Recently, increased surgeon experience and improved transcatheter valve systems have led to a global trend to use TAVI in patients with low or intermediate risk. Although cognitive impairment after cardiac surgery is well known, the effect of TAVI on cognitive function has not yet been adequately investigated. The aim of this study is to compare the occurrence and progression of delirium, postoperative cognitive decline (POCD), cerebral infarction, and health-related quality of life (QOL) in patients with intermediate risk for catheter-assisted (TAVI) and surgical (SAVR) aortic valve replacement.

Conditions

Postoperative Delirium; Postoperative Cognitive Dysfunction; Transcatheter Aortic Valve Replacement; Surgical Aortic Valve Replacement

Outcome Measures

Primary Outcomes (3)

• Number of participants with postoperative cognitive decline at 3 months after surgery, defined as a decrease between pre- and postoperative examinations of one standard deviation in at least 20% of all objective neuropsychological parameters

  The objective neuropsychological parameters measure cognitive domains like immediate memory span, free recall, recognition memory, selective attention, working memory, inhibition and word fluency. These cognitive domains will be measured with the following instruments: "Verbaler Lern- und Merkfähigkeitstest" (VLMT), "Trail Making Test A/B" (TMT), "Letter Number Span Test" (LNS), Block Tapping Test (BTT), "Regensburger Wortflüssigkeits-Test" (RWT), and "Syndrom-Kurz Test" (SKT).

  Immediately pre-surgery to 3 months post-surgery

• Number of participants with postoperative cognitive decline at the time of discharge from the acute clinic, defined as a decrease between the pre- and postoperative examinations of one standard deviation measured with the "Montreal Cognitive Assessment"

  The "Montreal Cognitive Assessment" (MOCA) is a screening procedure for general cognitive function.

  Immediately pre-surgery to approximately 1 week post-surgery

• Number of participants with postoperative delirium during the stay in the intensive care unit as assessed by the "Intensive Care Delirium Screening Checklist" (ICDSC)

  Postoperative delirium is defined as the occurrence of at least one delirious episode during a stay in the intensive care unit. The "Intensive Care Delirium Screening Checklist" (ICDSC) record the clinical symptoms of consciousness, attention, orientation, hallucinations, psychomotor retardation or agitation, speech, and changing symptoms by observing behavior and asking concrete questions to the patient.

  Immediately post-surgery to approximately 7 days post-surgery

Secondary Outcomes (6)

• Change from baseline cognitive failures in everyday life at 3 months after surgery as assessed by the "Cognitive Failures Questionnaire" (CFQ)

  Immediately pre-surgery to 3 months post-surgery

• Change from baseline health-related quality of life at 3 months after surgery as assessed by the "36-Item Short Form Health Survey" (SF36)

  Immediately pre-surgery to 3 months post-surgery

• Change from baseline anxiety at 3 months after surgery as assessed by the "Hospital Anxiety and Depression Scale" (HADS).

  Immediately pre-surgery to 3 months post-surgery

• Change from baseline depression at 3 months after surgery as assessed by the "Hospital Anxiety and Depression Scale" (HADS).

  Immediately pre-surgery to 3 months post-surgery

• Number of participants with postoperative acute ischemic lesions at the time of discharge from the acute clinic as assessed by magnetic resonance images (MRI).

  Once within the 6th-10th day immediately post-surgery

Study Arms (2)

Transcatheter Aortic Valve Implantation

EXPERIMENTAL

Procedure: Transcatheter Aortic Valve Implantation

Surgical Aortic Valve Replacement

ACTIVE COMPARATOR

Procedure: Surgical Aortic Valve Replacement

Interventions

Transcatheter Aortic Valve Implantation PROCEDURE

Transcatheter Aortic Valve Implantation

Transcatheter Aortic Valve Implantation

Surgical Aortic Valve Replacement PROCEDURE

Surgical Aortic Valve Replacement

Surgical Aortic Valve Replacement

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Heart team decision that both TAVI and SAVR are medically justified based on
• Degenerative aortic valve stenosis:
• Mean gradient \> 40 mmHg or
• Jet velocity \> 40 m/s or
• Surface of aortic valve \< 1.0 cm²
• Patient shows symptoms of aortic stenosis
• NYHA functional class ≥ II or
• Angina pectoris or
• Syncope
• Low to intermediate surgical risk (STS: 2-6%)
• A transfemoral or alternative access for TAVI can be implemented
• Patient has agreed in writing to participate in the study
• Patient is able to understand the patient information and sign it personally
• Patient agrees to undergo SAVR if randomization into the control group occurs
• Readiness for MRT examination and neuropsychological testing after 3 months

You may not qualify if:

• Congenital aortic valve defects
• Untreated clinically significant coronary artery disease or severe mitral or tricuspid insufficiency or mitral stenosis
• Previous heart surgery
• Percutaneous coronary intervention performed within one month prior to the study
• Hemodynamic instability requiring inotropic support or mechanical circulatory support
• Ischemic stroke or intracranial bleeding within the month before the start of the study
• Severe ventricular dysfunction with left ventricular ejection fraction \< 20% as measured by echocardiogram
• Hypertrophic obstructive cardiomyopathy or severe basal septum hypertrophy
• Echocardiographic detection of intracardiac mass, thrombus, vegetation, or endocarditis
• Any other atherosclerotic disease that is considered as a contraindication for isolated aortic valve surgery
• Symptomatic carotid or vertebral artery disease
• Existing neurological or psychiatric disease (particularly cerebral infarction, cranio- cerebral trauma, manifest depression or dementia) that may interfere with neuropsychological testing.
• Contraindications for MRI examination (e.g. cardiac pacemaker, vena cava filter, claustrophobia)

Sponsors & Collaborators

• Heart and Brain Research Group, Germany: lead

Study Sites (1)

Department of Cardiac Surgery, Kerckhoff-Klinik GmbH

Bad Nauheim, 61231, Germany

Location

MeSH Terms

Conditions

Emergence Delirium; Postoperative Cognitive Complications

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognitive Dysfunction; Cognition Disorders

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Martin Jünemann, Dr.med.M.Sc.

  Clinic for Neurology, University Hospital Giessen

  PRINCIPAL INVESTIGATOR

• Marius Butz, Dipl.-Psych.

  Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim

  PRINCIPAL INVESTIGATOR

• Tibo Gerriets, Prof.Dr.med.

  Department of Neurology, Gesundheitszentrum Wetterau

  PRINCIPAL INVESTIGATOR

• Markus Schönburg, Prof.Dr.med.

  Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim

  PRINCIPAL INVESTIGATOR

• Won-Keun Kim, Dr.med.

  Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 1, 2020
• Study Start: February 28, 2019
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: September 22, 2023

Record last verified: 2022-03

Locations

DE (1)