Skip to main content
OpenTrials
Completed

NCT Number: NCT00275769

CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Bradycardia Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Vancouver, British Columbia, Canada

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pacemaker

Device

Primary outcomes

  1. 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 outcomes

  1. Observe the variability of multiple pacing thresholds measured with ACM and VCM

  2. Observe visit time differences using automatic measurements versus traditional follow-up

  3. Observe the effects of Post Mode Switch Overdrive Pacing (PMOP) on AT/AF burden.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

  • Medtronic

Registry information

Official study title

Complete Automatic Pacing Threshold Utilization Recorded by EnPulse

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jan 12, 2006
Registry last updated
Dec 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.