Cognitive Outcome After Surgical and Transcatheter Aortic Valve Replacement (COSTA)

H

Heart and Brain Research Group, Germany

Status

Completed

Conditions

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

Treatments

Procedure: Transcatheter Aortic Valve Implantation
Procedure: Surgical Aortic Valve Replacement

Study type

Interventional

Funder types

Other

Identifiers

NCT04535076
MC 68/2017

Details and patient eligibility

About

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.

Full description

The present project is a substudy of the DEDICATE Trial (ID: NCT03112980). It is a randomized intervention study taking place at the Kerckhoff-Klink Bad Nauheim Germany (Campus Justus Liebig University Giessen) involving 100 patients undergoing aortic valve replacement (TAVI vs. SAVR) with a focus on cognitive outcome. A detailed assessment of psychological and health-related functions will be performed before intervention, during hospitalization and 3 months after intervention. During hospitalization, the occurrence and progression of delirium will be assessed with the Intensive Care Delirium Screening Checklist (ICDSC). Other cognitive data will be collected before and 3 months after surgery with a selected and comprehensive neuropsychological test battery, including the evaluation of attention, word fluency, executive functions and various functional areas of memory. In addition, parameters of health-related QOL will be collected before and 3 months after the intervention using the SF-36, and information on anxiety and depression will be collected using the Hospital Anxiety and Depression Scale (HADS). A few days after the intervention, magnetic resonance images of the brain will be acquired to assess cerebral infarction.

Enrollment

31 patients

Sex

All

Ages

65 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
  • Patients aged 65 to 85 years.
  • Native German speaker (since a neuropsychological test is language dependent)

Exclusion criteria

  • 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

31 participants in 2 patient groups

Transcatheter Aortic Valve Implantation
Experimental group
Treatment:
Procedure: Transcatheter Aortic Valve Implantation
Surgical Aortic Valve Replacement
Active Comparator group
Treatment:
Procedure: Surgical Aortic Valve Replacement

Trial contacts and locations

1

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Central trial contact

Martin Jünemann, Dr.med.M.Sc.; Marius Butz, Dipl.-Psych.

Data sourced from clinicaltrials.gov

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