An interventional study of Pacemaker in Arrhythmia and Bradycardia, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed at 57 sites in 2 countries. Per ClinicalTrials.gov, last updated 2008-12-11.
Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Not applicable and Interventional
This study compares the pacemaker's automatic pacing threshold measurements to the manual measurements conducted by a health care provider.
The purpose(s) of the study is (are) to evaluate several features available in EnPulse Series pacemaker and report the long term benefit of Atrial Capture Management (ACM) and Ventricular Capture Management (VCM) as demonstrated by accuracy in comparison with manual measurements and variability of ACM and VCM thresholds.
In addition, an evaluation of the timesaving and qualitative benefits of the device feature known as Quick Look II (the computer interface screen of the device programmer) will be measured through the use of a questionnaire completed by the health care professionals involved in patient follow-up care.
This is a one-to-one randomized, multicenter, prospective study in which patients receiving new EnPulse pacemaker implants will be randomized to each of three study arms, 1) routine manual follow-up and follow-up using the automatic features; 2) ACM diagnostics detail on or VCM diagnostics detail on; 3) PMOP on / off or PMOP off / on (6 month cycle).
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
This study's enrollment of 860 is above the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 239 studies on the registry; 6 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The automatic device features Atrial Capture Management and Ventricular Capture Management measure pacing thresholds and is compared to manual pacing thresholds observed at the 6 month follow-up visit
Observe the variability of multiple pacing thresholds measured with ACM and VCM
Observe visit time differences using automatic measurements versus traditional follow-up
Observe the effects of Post Mode Switch Overdrive Pacing (PMOP) on AT/AF burden.
This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.
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Medtronic Cardiac Rhythm and Heart Failure