CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse
Complete Automatic Pacing Threshold Utilization Recorded by EnPulse
1 other identifier
interventional
860
2 countries
57
Brief Summary
This study compares the pacemaker's automatic pacing threshold measurements to the manual measurements conducted by a health care provider.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2004
Typical duration for not_applicable
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 11, 2006
CompletedFirst Posted
Study publicly available on registry
January 12, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedDecember 11, 2008
December 1, 2008
2.5 years
January 11, 2006
December 10, 2008
Conditions
Keywords
Outcome Measures
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 (3)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Patient with mechanical tricuspid heart valves
- Patients with medical conditions that preclude the testing required by the protocol or limit study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic Cardiac Rhythm and Heart Failurelead
- Medtroniccollaborator
Study Sites (57)
Unknown Facility
Anchorage, Alabama, United States
Unknown Facility
Mobile, Alabama, United States
Unknown Facility
Fullerton, California, United States
Unknown Facility
Oceanside, California, United States
Unknown Facility
Redondo Beach, California, United States
Unknown Facility
Stanford, California, United States
Unknown Facility
Colorado Springs, Colorado, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Brandon, Florida, United States
Unknown Facility
Daytona Beach, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Sarasota, Florida, United States
Unknown Facility
Athens, Georgia, United States
Unknown Facility
Gainsville, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Peoria, Illinois, United States
Unknown Facility
Des Moines, Iowa, United States
Unknown Facility
Kansas City, Kansas, United States
Unknown Facility
Worcester, Maine, United States
Unknown Facility
Burlington, Massachusetts, United States
Unknown Facility
Petoskey, Michigan, United States
Unknown Facility
Saint Paul, Minnesota, United States
Unknown Facility
Jackson, Mississippi, United States
Unknown Facility
Columbia, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Flemington, New Jersey, United States
Unknown Facility
Newark, New Jersey, United States
Unknown Facility
Paramus, New Jersey, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
Fayetteville, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
High Point, North Carolina, United States
Unknown Facility
Akron, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Steubenville, Ohio, United States
Unknown Facility
Lawton, Oklahoma, United States
Unknown Facility
Tualatin, Oregon, United States
Unknown Facility
Altoona, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Pawtucket, Rhode Island, United States
Unknown Facility
Columbia, South Carolina, United States
Unknown Facility
Greenville, South Carolina, United States
Unknown Facility
Sioux Falls, South Dakota, United States
Unknown Facility
Knoxville, Tennessee, United States
Unknown Facility
Oak Ridge, Tennessee, United States
Unknown Facility
Forth Worth, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Spokane, Washington, United States
Unknown Facility
Charleston, West Virginia, United States
Unknown Facility
Wausau, Wisconsin, United States
Unknown Facility
North Vancouver, British Columbia, Canada
Unknown Facility
Kitchener, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Laval, Quebec, Canada
Unknown Facility
Québec, Quebec, Canada
Unknown Facility
Saskatoon, Saskatchewan, Canada
Related Publications (1)
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. doi: 10.1111/j.1540-8159.2010.02809.x. Epub 2010 Jun 2.
PMID: 20545869DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen W. Mester, MD
Tampa General Hospital
- PRINCIPAL INVESTIGATOR
Lawrence S. Rosenthal, MD
UMass Memorial Health
- PRINCIPAL INVESTIGATOR
Raymond Gendreau, MD
Cite di la Sante de Laval
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 11, 2006
First Posted
January 12, 2006
Study Start
March 1, 2004
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
December 11, 2008
Record last verified: 2008-12