Risk of Pacing-induced Cardiomyopathy (NCT04269733) | Clinical Trial Compass
CompletedNot Applicable
Risk of Pacing-induced Cardiomyopathy
Denmark153 participantsStarted 2020-05-01
Plain-language summary
This study will evaluate the association between right ventricular pacing and the risk of pacing-induced cardiomyopathy.
Who can participate
Age range18 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Pacing-induced cardiomyopathy
Timeframe: After ≥ 1 years of exposure to right ventricular pacing