Atrial Fibrillation, Bradycardia, Heart Failure, Congestive, Sick Sinus Syndrome, Ventricular Dysfunction
Conditions
Keywords
Right Ventricular Pacing, Persistent Atrial Fibrillation, Atrioventricular Conduction, Heart Failure Hospitalization, Cardiovascular Health Care Utilization, Sinus-node Disease, Minimized Ventricular Pacing
Brief summary
SAVE PACe is a large, prospective, single-blinded, randomized clinical trial with the main objective to study the effect of unnecessary right ventricular apical pacing on the clinical outcome of time to development of persistent AF.
Detailed description
Conventional dual-chamber pacing maintains atrioventricular synchrony but results in high percentages of ventricular pacing, which causes ventricular desynchronization and has been linked to an increased risk of atrial fibrillation in patients with sinus-node disease. Patients with sinus-node disease and intact atrioventricular conduction are randomly assigned to receive conventional dual-chamber pacing or dual-chamber minimal ventricular pacing with the use of new Medtronic pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization. The primary end point was time to persistent atrial fibrillation.
Interventions
DEVICEImplantable Pulse Generators
dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the time to development of persistent AF between all randomized subjects in the ON and OFF arms. | from Jan 2003 to Dec 2006 |
Secondary
| Measure | Time frame |
|---|---|
| To compare composite endpoint of AF and heart failure hospitalization (HFH), HFH, cardiovascular health care utilization, symptoms, HF medications, cumulative %, adverse events and incidence of stroke between the arms. | from Jan 2003 to Dec 2006 |
Countries
Canada, United States
Outcome results
None listed