CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse

December 10, 2008 updated by: Medtronic Cardiac Rhythm and Heart Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment

860

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada
    • British Columbia
      • North Vancouver, British Columbia, Canada
    • Ontario
      • Kitchener, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Laval, Quebec, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
  • United States
    • Alabama
      • Anchorage, Alabama, United States
      • Mobil, Alabama, United States
    • California
      • Fullerton, California, United States
      • Oceanside, California, United States
      • Redondo Beach, California, United States
      • Stanford, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Brandon, Florida, United States
      • Daytona Beach, Florida, United States
      • Orlando, Florida, United States
      • Sarasota, Florida, United States
    • Georgia
      • Athens, Georgia, United States
      • Gainsville, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Peoria, Illinois, United States
    • Iowa
      • Des Moines, Iowa, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Maine
      • Worcester, Maine, United States
    • Massachusetts
      • Burlington, Massachusetts, United States
    • Michigan
      • Petoskey, Michigan, United States
    • Minnesota
      • St. Paul, Minnesota, United States
    • Mississippi
      • Jackson, Mississippi, United States
    • Missouri
      • Columbia, Missouri, United States
      • St. Louis, Missouri, United States
    • New Jersey
      • Flemington, New Jersey, United States
      • Newark, New Jersey, United States
      • Paramus, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Fayetteville, New York, United States
      • New York, New York, United States
    • North Carolina
      • High Point, North Carolina, United States
    • Ohio
      • Akron, Ohio, United States
      • Cleveland, Ohio, United States
      • Steubenville, Ohio, United States
    • Oklahoma
      • Lawton, Oklahoma, United States
    • Oregon
      • Tualatin, Oregon, United States
    • Pennsylvania
      • Altoona, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • Rhode Island
      • Pawtucket, Rhode Island, United States
    • South Carolina
      • Columbia, South Carolina, United States
      • Greenville, South Carolina, United States
    • South Dakota
      • Sioux Falls, South Dakota, United States
    • Tennessee
      • Knoxville, Tennessee, United States
      • Oak Ridge, Tennessee, United States
    • Texas
      • Forth Worth, Texas, United States
      • Houston, Texas, United States
    • Virginia
      • Richmond, Virginia, United States
    • Washington
      • Spokane, Washington, United States
    • West Virginia
      • Charleston, West Virginia, United States
    • Wisconsin
      • Wausau, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Collaborators

Medtronic

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

January 11, 2006

First Submitted That Met QC Criteria

January 11, 2006

First Posted (Estimate)

January 12, 2006

Study Record Updates

Last Update Posted (Estimate)

December 11, 2008

Last Update Submitted That Met QC Criteria

December 10, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 229

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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