CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse

Complete Automatic Pacing Threshold Utilization Recorded by EnPulse

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00275769

Enrollment

860

Registered

2006-01-12

Start date

2004-03-31

Completion date

2006-09-30

Last updated

2008-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia, Bradycardia

Keywords

Arrhythmia, Bradycardia, Cardiac Pacemaker Artificial

Brief 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).

Interventions

DEVICEPacemaker

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026