SAVEPACe - Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Con… (NCT00284830) | Clinical Trial Compass
CompletedNot Applicable
SAVEPACe - Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction
United States, Canada1,070 participantsStarted 2003-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To compare the time to development of persistent AF between all randomized subjects in the ON and OFF arms.