|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00275769 |
|
Date of registration:
|
11/01/2006 |
|
Primary sponsor: |
|
|
Public title:
|
CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse
|
|
Scientific title:
|
Complete Automatic Pacing Threshold Utilization Recorded by EnPulse |
|
Date of first enrolment:
|
March 2004 |
|
Target sample size:
|
860 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00275769 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label
|
|
|
Countries of recruitment
|
|
Canada
|
United States
| | | | | | |
|
Contacts
|
|
Name:
|
Raymond Gendreau, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Cite di la Sante de Laval |
|
|
Name:
|
Stephen W. Mester, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Tampa General Hospital |
|
|
Name:
|
Lawrence S. Rosenthal, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
UMass Memorial Medical Center |
|
|
Key inclusion & exclusion 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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Arrhythmia
|
|
Bradycardia
|
|
Intervention(s)
|
|
Device: Pacemaker
|
|
Primary Outcome(s)
|
|
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(s)
|
|
Observe the effects of Post Mode Switch Overdrive Pacing (PMOP) on AT/AF burden.
|
|
Observe the variability of multiple pacing thresholds measured with ACM and VCM
|
|
Observe visit time differences using automatic measurements versus traditional follow-up
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|