CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00275769
First received: January 11, 2006
Last updated: December 10, 2008
Last verified: December 2008
  Purpose

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


Condition Intervention
Arrhythmia
Bradycardia
Device: Pacemaker

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Complete Automatic Pacing Threshold Utilization Recorded by EnPulse

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Estimated Enrollment: 860
Study Start Date: March 2004
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275769

  Show 57 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Medtronic
Investigators
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
  More Information

No publications provided by Medtronic Cardiac Rhythm Disease Management

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00275769     History of Changes
Other Study ID Numbers: 229
Study First Received: January 11, 2006
Last Updated: December 10, 2008
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Arrhythmia
Bradycardia
Cardiac Pacemaker Artificial

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Bradycardia
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014