SAVEPACe - Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction (SAVEPACe)
Sick Sinus Syndrome, Heart Failure, Congestive, Atrial Fibrillation
About this trial
This is an interventional prevention trial for Sick Sinus Syndrome focused on measuring Right Ventricular Pacing, Persistent Atrial Fibrillation, Atrioventricular Conduction, Heart Failure Hospitalization, Cardiovascular Health Care Utilization, Sinus-node Disease, Minimized Ventricular Pacing
Eligibility Criteria
Inclusion Criteria: 18 years of age and older Willing and able to give informed consent Willing and able to comply with the study follow-up schedule Class I/ClassII indications for dual chamber pacing Initial implant of a Kappa 700, Kappa 900, EnPulse, or EnRhythm dual chamber IPG Demonstrate 1 to 1 conduction and a QRS interval of < 120ms at 100 beats per minutes for a period of nine seconds while atrial pacing Exclusion Criteria: Less than 18 years of age Unwilling or unable to give informed consent Unwilling or unable to commit to follow-up schedule Medical conditions that would preclude the testing required by the protocol or limit study participation Enrolled or intend to participate in another clinical trial during the course of this study A life expectancy of less than 2 years History of continuous atrial fibrillation for the 6 months prior to screen visit Two or more cardioversions, chemical or electrical, within the past 6 months prior to screen History of persistent second or third degree atrioventricular block A prior implant of pacemaker or defibrillator device A baseline, pre-paced QRS >120 ms on surface ECG Failure of the 1 to 1 atrioventricular conduction test Anticipated major cardiac surgery within the course of the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
1
2
dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization
conventional dual-chamber pacing