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ArrhythmiaNCT00275769

CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse

A study testing Pacemaker in people with Arrhythmia and Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 57 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Any age
Conditions the study is for
Arrhythmia, Bradycardia
What is being tested?
Pacemaker
Type of treatment
Medical device
How many people
860 participants
Where
57 sitesin 2 countries
Study dates
Mar 2004to Sep 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • Patient with mechanical tricuspid heart valves
  • Patients with medical conditions that preclude the testing required by the protocol or limit study participation

Trial locations and contacts

57 sites in 2 countries.

57 sites in 2 countries

United States51 sites

  • Study site

    Akron, Ohio

  • Study site

    Albuquerque, New Mexico

  • Study site

    Altoona, Pennsylvania

  • Study site

    Anchorage, Alabama

  • Study site

    Athens, Georgia

  • Study site

    Brandon, Florida

  • Study site

    Burlington, Massachusetts

  • Study site

    Charleston, West Virginia

  • Study site

    Chicago, Illinois

  • Study site

    Cleveland, Ohio

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbia, Missouri

  • Study site

    Columbia, South Carolina

  • Study site

    Daytona Beach, Florida

  • Study site

    Des Moines, Iowa

  • Study site

    Fayetteville, New York

  • Study site

    Flemington, New Jersey

  • Study site

    Forth Worth, Texas

  • Study site

    Fullerton, California

  • Study site

    Gainsville, Georgia

  • Study site

    Greenville, South Carolina

  • Study site

    High Point, North Carolina

  • Study site

    Houston, Texas

  • Study site

    Jackson, Mississippi

  • Study site

    Kansas City, Kansas

  • Study site

    Knoxville, Tennessee

  • Study site

    Lawton, Oklahoma

  • Study site

    Mobile, Alabama

  • Study site

    New York, New York

  • Study site

    Newark, New Jersey

  • Study site

    Oak Ridge, Tennessee

  • Study site

    Oceanside, California

  • Study site

    Orlando, Florida

  • Study site

    Paramus, New Jersey

  • Study site

    Pawtucket, Rhode Island

  • Study site

    Peoria, Illinois

  • Study site

    Petoskey, Michigan

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Redondo Beach, California

  • Study site

    Richmond, Virginia

  • Study site

    Saint Paul, Minnesota

  • Study site

    Sarasota, Florida

  • Study site

    Sioux Falls, South Dakota

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Stanford, California

  • Study site

    Steubenville, Ohio

  • Study site

    Tualatin, Oregon

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Wausau, Wisconsin

  • Study site

    Worcester, Maine

Other trials in United States

Canada6 sites

  • Study site

    Kitchener, Ontario

  • Study site

    Laval, Quebec

  • Study site

    North Vancouver, British Columbia

  • Study site

    Québec, Quebec

  • Study site

    Saskatoon, Saskatchewan

  • Study site

    Toronto, Ontario

Other trials in Canada

About this study

Official title: 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.

Read the 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).

Being tested
Pacemaker
Keywords
Arrhythmia, Bradycardia, Cardiac Pacemaker Artificial
Medical subject headings
Arrhythmias, Cardiac, Bradycardia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PacemakerDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  1. Observe the variability of multiple pacing thresholds measured with ACM and VCM

  2. Observe visit time differences using automatic measurements versus traditional follow-up

  3. Observe the effects of Post Mode Switch Overdrive Pacing (PMOP) on AT/AF burden.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2006 (estimated)
  2. Study startMar 2004
  3. Primary completionSep 2006
  4. Study completionSep 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
860 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00275769
Sponsor's protocol ID
229
Status last verified
Dec 2008
First submitted
11 Jan 2006
Last updated
11 Dec 2008
Results posted
No

Publications

  • 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.

    PubMed 20545869

Questions about this trial

What is this clinical trial studying?

A study testing Pacemaker in people with Arrhythmia and Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 57 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00275769, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2008.

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