ClinicalTrials.gov
ClinicalTrials.gov Menu

CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00275769
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : December 11, 2008
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure

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

Condition or disease Intervention/treatment Phase
Arrhythmia Bradycardia Device: Pacemaker Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Enrollment : 860 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Official Title: Complete Automatic Pacing Threshold Utilization Recorded by EnPulse
Study Start Date : March 2004
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006



Primary Outcome Measures :
  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 Outcome Measures :
  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.


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275769


  Show 57 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00275769     History of Changes
Other Study ID Numbers: 229
First Posted: January 12, 2006    Key Record Dates
Last Update Posted: December 11, 2008
Last Verified: December 2008

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Arrhythmia
Bradycardia
Cardiac Pacemaker Artificial

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