Risk of Pacing-induced Cardiomyopathy

NCT04269733 | Completed DMC

• 1 other identifier: 2020-015
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the association between right ventricular pacing and the risk of pacing-induced cardiomyopathy.

Conditions

Pacemaker DDD; Atrioventricular Block; Pacing-Induced Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Pacing-induced cardiomyopathy

  Time to development of PICM. PICM is defined as ≥ 10% decrease in LVEF resulting in LVEF \< 50% after pacemaker implantation.

  After ≥ 1 years of exposure to right ventricular pacing

Secondary Outcomes (5)

• Composite endpoint of new-onset heart failure

  After ≥ 1 year of exposure to right ventricular pacing

• Change in LVEF

  After ≥ 1 year of exposure to right ventricular pacing

• New-onset atrial fibrillation and/or atrial flutter

  After ≥ 1 years of exposure to right ventricular pacing

• Change in LV end-diastolic volume

  After ≥ 1 years of exposure to right ventricular pacing

• Change in LV end-systolic volume

  After ≥ 1 years of exposure to right ventricular pacing

Study Arms (1)

Subjects with a DDD-pacemaker due to high-degree AV block

Device: Right ventricular pacing

Interventions

Right ventricular pacing DEVICE

Right ventricular pacing from a DDD pacemaker implanted due to high-degree AV block

Subjects with a DDD-pacemaker due to high-degree AV block

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with a normal or near-normal ejection fraction prior to pacemaker implantation who received a DDD-pacemaker due to high-degree AV block ≥ 1 years prior to screening.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Svend Andersens Foundation: collaborator
• Peacs: collaborator
• Aalborg University: collaborator
• Karl G Andersens Fond: collaborator
• Sygekassernes Helsefond: collaborator

Study Sites (1)

Department of Cardiology, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Atrioventricular Block

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, clinical assistant, PhD student

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: May 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)