CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse
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|ClinicalTrials.gov Identifier: NCT00275769|
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : December 11, 2008
|Condition or disease||Intervention/treatment||Phase|
|Arrhythmia Bradycardia||Device: Pacemaker||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||860 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Complete Automatic Pacing Threshold Utilization Recorded by EnPulse|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||September 2006|
|Actual Study Completion Date :||September 2006|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275769
Show 57 Study Locations
|Principal Investigator:||Stephen W. Mester, MD||Tampa General Hospital|
|Principal Investigator:||Lawrence S. Rosenthal, MD||UMass Memorial Medical Center|
|Principal Investigator:||Raymond Gendreau, MD||Cite di la Sante de Laval|