Clinical trial NCT00275769: CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse
Official title: Complete Automatic Pacing Threshold Utilization Recorded by EnPulse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmia
Bradycardia
Keywords: Arrhythmia
Bradycardia
Cardiac Pacemaker Artificial
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2006-01-12
Enrollment: 860
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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

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 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

Primary outcomes:
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
Secondary outcomes:
measure: Observe the variability of multiple pacing thresholds measured with ACM and VCM
measure: Observe visit time differences using automatic measurements versus traditional follow-up
measure: Observe the effects of Post Mode Switch Overdrive Pacing (PMOP) on AT/AF burden.
Other outcomes:
Locations:
city: Anchorage
country: United States
state: Alabama
city: Mobil
country: United States
state: Alabama
city: Fullerton
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Redondo Beach
country: United States
state: California
city: Stanford
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Brandon
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Athens
country: United States
state: Georgia
city: Gainsville
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: Des Moines
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Worcester
country: United States
state: Maine
city: Burlington
country: United States
state: Massachusetts
city: Petoskey
country: United States
state: Michigan
city: St. Paul
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: Columbia
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Flemington
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Paramus
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Fayetteville
country: United States
state: New York
city: New York
country: United States
state: New York
city: High Point
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Steubenville
country: United States
state: Ohio
city: Lawton
country: United States
state: Oklahoma
city: Tualatin
country: United States
state: Oregon
city: Altoona
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pawtucket
country: United States
state: Rhode Island
city: Columbia
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Sioux Falls
country: United States
state: South Dakota
city: Knoxville
country: United States
state: Tennessee
city: Oak Ridge
country: United States
state: Tennessee
city: Forth Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Charleston
country: United States
state: West Virginia
city: Wausau
country: United States
state: Wisconsin
city: North Vancouver
country: Canada
state: British Columbia
city: Kitchener
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Laval
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Quebec
country: Canada
Study officials:
affiliation: Tampa General Hospital
name: Stephen W. Mester, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMass Memorial Health
name: Lawrence S. Rosenthal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cite di la Sante de Laval
name: Raymond Gendreau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.