Chronically (i.e. Implanted for at Least Six Months) Dual-chamber Pacemaker, Stable Cardiac Status (i.e. no Hospitalizations or Cardiac Medication Changes Within 3 Months)
Conditions
Brief summary
We intend to examine the effects of temporary elevation of atrial wall stress by shortening of the atrioventricular delay in patients with dual-chamber pacemakers.
Interventions
OTHERshort AVD pacing ; prior (stable) programming
short AVD pacing prior (stable) programming
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Chronically (i.e. implanted for at least six months) dual-chamber pacemaker * Stable cardiac status (i.e. no hospitalizations or cardiac medication changes within 3 months) * Ability to provide informed consent
Exclusion criteria
* Age \<18 years or \>80 years * Pregnancy (if pregnancy is suspected, a urine pregnancy test will be performed) * Recent (within 12 months) left ventricular ejection fraction \<50% * Significant valvular heart disease (mitral regurgitation of greater than mild severity, any degree of mitral stenosis, aortic stenosis or insufficiency of greater than mild severity) * Prior coronary artery bypass graft or valve surgery, recent (i.e. within 3 months) acute coronary syndrome or percutaneous coronary intervention, or chronic stable angina * History of clinically important atrial or ventricular tachyarrhythmias, defined as complex ventricular ectopy (i.e. couplets, triplets, or ventricular tachycardia), AF, atrial tachycardia, or other supraventricular tachycardias not cured with prior ablative therapy). * Significant chronic systemic inflammatory or neoplastic disease * Chronic renal or hepatic insufficiency. Renal insufficiency will be defined as a creatinine clearance of less than 20 cc/min. Evidence of hepatic insufficiency will consist of abnormal synthetic function (INR \>1.4 without oral anticoagulant use, albumin \< 3.0 mg/dL) or abnormal clearance function (total bilirubin \>2.0). * Uncorrected thyroid abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum biomarker concentrations | 30 days |
Countries
United States
Outcome results
None listed