Table 1 Clinical study variables
| Category | Data points |
|---|---|
| Demographics |
1. Date of birth 2. Age at time of pacemaker (PPM) implant/generator change 3. Gender (male/female) |
| Baseline medical History |
1. Left ventricle ejection fraction (LVEF) prior to implant (%) 2. Hypertension (HTN) 3. Diabetes mellitus (DM) 4. History of trans-catheter aortic valve replacement 5. Coronary artery disease (CAD) 6. History of cardiac surgery |
| Baseline medications | 1. Medications including antiarrhythmics use (angiotensin-converting enzyme (ACE) inhibitor; angiotensin receptor blocker (ARB); beta-blocker; calcium channel blocker; amiodarone, dofetilide, dronedarone, flecainide, propafenone, sotalol) |
| Baseline data at the start of monitoring period |
1. Date of PPM implant or generator change 2. Indication for PPM (atrioventricular conduction block [AVB], or sinoatrial nodal disease [SAND] [16]) 3. Device manufacturer (Medtronic™ and Boston Scientific™) 4. Mode of pacing (dual paced, dual sensed, dual inhibited/triggered [DDD], managed ventricular pacing, or other) 5. Minimum pacing rate (n/min) 6. Maximum tracking rate (n/min) 7. Rate response (yes/no) |
| Arrhythmia burden and RVP% during monitoring period |
1. Date of start of monitoring period 2. Date of end of monitoring period a. Total number of days included in analysis period 3. Number of non-sustained ventricular tachycardia (NSVT) (> 4 beats but lasting < 30 s) episodes during monitoring period (VT detection programmed ≥ 150 and ≥ 160 beats per minute for Medtronic™ and Boston Scientific™, respectively) 4. NSVT (> 4 beats but lasting < 30 s) burden (#/100 days) 5. Number of premature ventricular contraction (PVC) runs of 2–4 beats during monitoring period (#/h) 6. Isolated PVC burden (#/h) 7. Atrial fibrillation (AF) burden (%; cumulative total time spent in atrial high rate episodes/total time of monitoring * 100) 8. Average percentage of right ventricular (RV) pacing over monitoring period (%; cumulative total time of RVP/total time of monitoring*100) |
| Clinical Outcomes |
1. LVEF after PPM implant a. Measured by echocardiography, or imaging stress test b. Time from PPM implant to LVEF determination (days) c. LVEF (%) 2. Stress test after PPM implant a. Type of stress test b. Stress test positive for ischemia or infarction (yes/no) c. Time from PPM implant to stress test 3. Device upgrade (none, implantable cardioverter defibrillator [ICD], biventricular PPM [Bi-VPPM], biventricular ICD [Bi-VICD]) a. Date of upgrade b. Time from PPM implant to upgrade 4. New medications initiation including antiarrhythmics use (angiotensin-converting enzyme (ACE) inhibitor; angiotensin receptor blocker (ARB); beta-blocker; calcium channel blocker; amiodarone, dofetilide, dronedarone, flecainide, propafenone, sotalol) 5. Hospitalization related to cardiac condition a. Date of hospitalization b. Indication for hospitalization 6. Death a. Date of death b. Cause of death if known |