NCT00275769

CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse

Complete Automatic Pacing Threshold Utilization Recorded by EnPulse

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 860 (planned)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study compares the pacemaker's automatic pacing threshold measurements to the manual measurements conducted by a health care provider.

Detailed description

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).

Conditions

• Arrhythmia
• Bradycardia

Interventions

Type	Name	Description
DEVICE	Pacemaker

Timeline

• Start date: 2004-03-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2006-01-12
• Last updated: 2008-12-11

Locations

57 sites across 2 countries: United States, Canada