CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse

Arrhythmia Clinical Trial

Official title:

Complete Automatic Pacing Threshold Utilization Recorded by EnPulse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275769
• Other study ID #: 229
• Status: Completed
• Phase: N/A
• First received: January 11, 2006
• Last updated: December 10, 2008
• Start date: March 2004
• Est. completion date: September 2006

Study information

• Verified date: December 2008
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 860
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients that meet ACC/AHA/NASPE 2002 class I or II dual chamber pacing indications (intended for a Pacing Mode programmed to DDD or DDDR)

Exclusion Criteria:

• Patient with mechanical tricuspid heart valves

• Patients with medical conditions that preclude the testing required by the protocol or limit study participation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arrhythmia
• Bradycardia

Intervention

Device:
• Pacemaker

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management	Medtronic

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Observe the variability of multiple pacing thresholds measured with ACM and VCM
Secondary	Observe visit time differences using automatic measurements versus traditional follow-up
Secondary	Observe the effects of Post Mode Switch Overdrive Pacing (PMOP) on AT/AF burden.