Status:
COMPLETED
Risk of Pacing-induced Cardiomyopathy
Lead Sponsor:
Aalborg University Hospital
Collaborating Sponsors:
Svend Andersens Foundation
Peacs
Conditions:
Pacemaker DDD
Atrioventricular Block
Eligibility:
All Genders
18-90 years
Brief Summary
This study will evaluate the association between right ventricular pacing and the risk of pacing-induced cardiomyopathy.
Detailed Description
Background: Right ventricular (RV) pacing may lead to pacing-induced cardiomyopathy (PICM) and heart failure (HF). The detrimental effects of RV pacing have been attributed to the abnormal and dyssyn...
Eligibility Criteria
Inclusion
- Male or female ≥ 18 years
- De novo DDD PM implanted at Aalborg University Hospital
- PM implantation due to advanced AV block
- Duration of pacemaker treatment ≥ 1 year at time of screening
- Normal LVEF (≥50%) prior to PM implantation
- Actively attending follow-up at the PM outpatient clinic at Aalborg University Hospital after PM implantation
Exclusion
- No written informed consent
- Baseline TTE not available or insufficient quality for assessment of LVEF
- Contraindications to a new contrast CT if no previous contrast-enhanced cardiac CT, showing RV lead position, is available
- RV pacing load \< 40%.
- Deceased
- Not attending follow-up at the PM outpatient clinic at Aalborg University Hospital after PM implantation
- Device complications with removal of original implanted pacing lead \> 3 months after primary implantation
- Subjects with severe ischemic heart disease and severe valvular heart disease.
- Terminal illness or unable to provide informed consent at time of screening
Key Trial Info
Start Date :
May 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT04269733
Start Date
May 1 2020
End Date
August 1 2021
Last Update
August 12 2021
Active Locations (1)
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1
Department of Cardiology, Aalborg University Hospital
Aalborg, Denmark, 9000