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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
History of Changes

January 11, 2006
December 10, 2008
March 2004
September 2006   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT00275769 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse
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.

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).
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
  • Arrhythmia
  • Bradycardia
Device: Pacemaker
Not Provided
Rosenthal LS, Mester S, Rakovec P, Penaranda JB, Sherman JR, Sheldon TJ, Zeng C, Wang P; CAPTURE Trial Investigators. Factors influencing pacemaker generator longevity: results from the complete automatic pacing threshold utilization recorded in the CAPTURE Trial. Pacing Clin Electrophysiol. 2010 Aug;33(8):1020-30. Epub 2010 Jun 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
860
September 2006
September 2006   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00275769
229
Not Provided
Not Provided
Medtronic Cardiac Rhythm Disease Management
Medtronic
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
Medtronic Cardiac Rhythm Disease Management
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP