CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse

NCT ID: NCT00275769

Last Updated: 2008-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

860 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-09-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Arrhythmia Bradycardia

Keywords

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Arrhythmia Bradycardia Cardiac Pacemaker Artificial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

NONE

Interventions

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Pacemaker

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Principal Investigators

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Stephen W. Mester, MD

Role: PRINCIPAL_INVESTIGATOR

Tampa General Hospital

Lawrence S. Rosenthal, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Memorial Health

Raymond Gendreau, MD

Role: PRINCIPAL_INVESTIGATOR

Cite di la Sante de Laval

Locations

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Anchorage, Alabama, United States

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Mobile, Alabama, United States

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Fullerton, California, United States

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Oceanside, California, United States

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Redondo Beach, California, United States

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Stanford, California, United States

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Colorado Springs, Colorado, United States

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Washington D.C., District of Columbia, United States

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Brandon, Florida, United States

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Daytona Beach, Florida, United States

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Orlando, Florida, United States

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Sarasota, Florida, United States

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Athens, Georgia, United States

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Gainsville, Georgia, United States

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Chicago, Illinois, United States

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Peoria, Illinois, United States

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Des Moines, Iowa, United States

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Kansas City, Kansas, United States

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Worcester, Maine, United States

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Burlington, Massachusetts, United States

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Petoskey, Michigan, United States

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Saint Paul, Minnesota, United States

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Jackson, Mississippi, United States

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Columbia, Missouri, United States

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St Louis, Missouri, United States

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Flemington, New Jersey, United States

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Newark, New Jersey, United States

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Paramus, New Jersey, United States

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Albuquerque, New Mexico, United States

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Fayetteville, New York, United States

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New York, New York, United States

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High Point, North Carolina, United States

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Akron, Ohio, United States

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Cleveland, Ohio, United States

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Steubenville, Ohio, United States

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Lawton, Oklahoma, United States

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Tualatin, Oregon, United States

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Altoona, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pawtucket, Rhode Island, United States

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Columbia, South Carolina, United States

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Greenville, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Knoxville, Tennessee, United States

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Oak Ridge, Tennessee, United States

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Forth Worth, Texas, United States

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Houston, Texas, United States

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Richmond, Virginia, United States

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Spokane, Washington, United States

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Charleston, West Virginia, United States

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Wausau, Wisconsin, United States

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North Vancouver, British Columbia, Canada

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Kitchener, Ontario, Canada

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Toronto, Ontario, Canada

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Laval, Quebec, Canada

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Québec, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 20545869 (View on PubMed)

Other Identifiers

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229

Identifier Type: -

Identifier Source: org_study_id