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CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse

10. december 2008 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Enhed: Pacemaker

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding

860

Fase

Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Barn
Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Tildeling: Randomiseret
Interventionel model: Faktoriel opgave
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
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

Sekundære resultatmål

Resultatmål
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Samarbejdspartnere

Medtronic

Efterforskere

Ledende efterforsker: Stephen W. Mester, MD, Tampa General Hospital
Ledende efterforsker: Lawrence S. Rosenthal, MD, UMass Memorial Medical Center
Ledende efterforsker: Raymond Gendreau, MD, Cite di la Sante de Laval

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2004

Primær færdiggørelse (Faktiske)

1. september 2006

Studieafslutning (Faktiske)