Status:
SUSPENDED
How is COGNItive Function Affected by Cardiac Resynchronisation Therapy?
Lead Sponsor:
Royal Cornwall Hospitals Trust
Conditions:
Cognitive Impairment
Cognitive Change
Eligibility:
All Genders
20-89 years
Brief Summary
The primary objective of COGNI-CRT is to assess whether Cardiac Resynchronisation Therapy (CRT) can improve cognitive function in patients with systolic HF (LVEF ≤35%), when compared to a control grou...
Detailed Description
Purpose: The purpose of this clinical investigation is to assess whether cardiac resynchronisation therapy (CRT) can improve cognitive function in patients with systolic heart failure (Left Ventricul...
Eligibility Criteria
Inclusion
- Undergoing implant of a CRT system with an LVEF of ≤35% (main group), or ICD or PPM system with an LVEF of ≤35% (control group)
- Are 20 - 89 years of age
- Be able to provide written informed consent prior to investigational related procedure, and be willing and able to comply with the described protocols and follow-up schedules listed in the PIS
- Be literate to a level in which the cognitive function tests can be completed effectively
- Mental capacity to provide informed consent and undertake cognitive function tests
- Geographically stable and able to return for the Post-Implant 6-Month Device Follow-Up Visit
Exclusion
- Are ≤19 years of age (due to specifications outlined in cognitive function test requirements)
- Are ≥90 years of age (due to specifications outlined in cognitive function test requirements)
- Are pregnant at time of enrolment
- Is participating in an investigational drug investigation
- Be experiencing a condition at the time of data collection which affects mental capacity (lack capacitiy), such as dementia, Alzheimer's, psychosis, schizophrenia (excluding depression and anxiety).
- Recent Cerebral Vascular Event (CVE) which may have affected cognitive function
- Heavy substance abuse, drugs or alcohol
Key Trial Info
Start Date :
June 21 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 14 2024
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT03755570
Start Date
June 21 2019
End Date
January 14 2024
Last Update
August 2 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal Cornwall Hospital NHS Trust
Truro, Cornwall, United Kingdom, TR13LQ