About this trial
The investigators will seek to determine the effects of different heart rates on both stroke volume and cardiac output using non-invasive hemodynamic assessments. In order to safely manipulate the HR, the investigators will study patients with permanent pacemakers in whom heart rate manipulation can be done in a safe and non-invasive manner.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-70 years (inclusive)
Implanted permanent pacemaker or implanted defibrillator capable of atrial and ventricular pacing
LV ejection fraction >50%
Disqualifiers
Unable or unwilling to provide informed consent
Clinical need for a cardiac resynchronization device
Trial design
Single group
Treatments tested in this trial
Pacing
DeviceAssess the non-invasively determined stroke volume and cardiac output response at different paced heart rates in patients with a cardiac pacemaker or implanted defibrillator with preserved ejection fractions (LVEF≥50%)
Treatment groups
Trial outcomes
Primary outcomes
Change in cardiac output while atrial pacing at lower and higher rates while supine
Change in cardiac output (CO) when atrial pacing at 80 bpm \& 120 bpm while supine. CO = HR x Stroke volume (SV)
Secondary outcomes
Change in cardiac output at lower and higher ventricular (VVI) paced rates while supine
Change in Cardiac output at ventricular (VVI) paced rates when it is lower (50-70 bpm) and higher (130 bpm) while supine
Change of cardiac output at lower and higher atrial (AAI) paced rates while supine versus while upright
Change of cardiac output at lower and higher atrial (AAI) paced rates while supine versus while upright at different paced rates
Change of cardiac output at lower and higher ventricular (VVI) paced rates while supine versus while upright
Change of cardiac output at lower and higher ventricular (VVI) paced rates while supine versus while upright at different paced rates
Change in stroke volume at lower and higher atrial paced rates while tilted up
Change in stroke volume at lower (50-70 bpm) vs. higher (130 bpm) atrial paced rates while tilted up
Sponsors and contacts
Click on the lead sponsor to view all of their trials.