SAVEPACe - Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction

Last updated: February 26, 2008
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Overall Status: Completed

Phase

N/A

Condition

Congestive Heart Failure

Heart Defect

Low Blood Pressure (Hypotension)

Treatment

N/A

Clinical Study ID

NCT00284830
191
  • Ages > 18
  • All Genders

Study Summary

SAVE PACe is a large, prospective, single-blinded, randomized clinical trial with the main objective to study the effect of unnecessary right ventricular apical pacing on the clinical outcome of time to development of persistent AF.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years of age and older

  • Willing and able to give informed consent

  • Willing and able to comply with the study follow-up schedule

  • Class I/ClassII indications for dual chamber pacing

  • Initial implant of a Kappa 700, Kappa 900, EnPulse, or EnRhythm dual chamber IPG

  • Demonstrate 1 to 1 conduction and a QRS interval of < 120ms at 100 beats per minutesfor a period of nine seconds while atrial pacing

Exclusion

Exclusion Criteria:

  • Less than 18 years of age

  • Unwilling or unable to give informed consent

  • Unwilling or unable to commit to follow-up schedule

  • Medical conditions that would preclude the testing required by the protocol or limitstudy participation

  • Enrolled or intend to participate in another clinical trial during the course of thisstudy

  • A life expectancy of less than 2 years

  • History of continuous atrial fibrillation for the 6 months prior to screen visit

  • Two or more cardioversions, chemical or electrical, within the past 6 months prior toscreen

  • History of persistent second or third degree atrioventricular block

  • A prior implant of pacemaker or defibrillator device

  • A baseline, pre-paced QRS >120 ms on surface ECG

  • Failure of the 1 to 1 atrioventricular conduction test

  • Anticipated major cardiac surgery within the course of the study

Study Design

Total Participants: 1070
Study Start date:
January 01, 2003
Estimated Completion Date:
February 29, 2008

Study Description

Conventional dual-chamber pacing maintains atrioventricular synchrony but results in high percentages of ventricular pacing, which causes ventricular desynchronization and has been linked to an increased risk of atrial fibrillation in patients with sinus-node disease.

Patients with sinus-node disease and intact atrioventricular conduction are randomly assigned to receive conventional dual-chamber pacing or dual-chamber minimal ventricular pacing with the use of new Medtronic pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization. The primary end point was time to persistent atrial fibrillation.

Connect with a study center

  • Vancouver,, British Columbia
    Canada

    Site Not Available

  • Winnipeg, Manitoba
    Canada

    Site Not Available

  • Sainte-Foy, Quebec
    Canada

    Site Not Available

  • Trois Rivieres, Quebec
    Canada

    Site Not Available

  • Phoenix, Arizona
    United States

    Site Not Available

  • Scottsdale, Arizona
    United States

    Site Not Available

  • Conway,, Arkansas
    United States

    Site Not Available

  • Glendale, California
    United States

    Site Not Available

  • La Mesa, California
    United States

    Site Not Available

  • Santa Rosa, California
    United States

    Site Not Available

  • Boulder, Colorado
    United States

    Site Not Available

  • Denver, Colorado
    United States

    Site Not Available

  • Clearwater, Florida
    United States

    Site Not Available

  • Ft Pierce, Florida
    United States

    Site Not Available

  • Lakeland, Florida
    United States

    Site Not Available

  • Miami Beach, Florida
    United States

    Site Not Available

  • Orlando, Florida
    United States

    Site Not Available

  • Verro Beach, Florida
    United States

    Site Not Available

  • Atlanta, Georgia
    United States

    Site Not Available

  • Tifton,, Georgia
    United States

    Site Not Available

  • Maywood, Illinois
    United States

    Site Not Available

  • Rockford, Illinois
    United States

    Site Not Available

  • Lexington, Kentucky
    United States

    Site Not Available

  • LaCombe, Louisiana
    United States

    Site Not Available

  • Annapolis, Maryland
    United States

    Site Not Available

  • Salisbury, Maryland
    United States

    Site Not Available

  • Boston, Massachusetts
    United States

    Site Not Available

  • Worcester, Massachusetts
    United States

    Site Not Available

  • Ann Arbor, Michigan
    United States

    Site Not Available

  • Grand Rapids, Michigan
    United States

    Site Not Available

  • Southfield, Michigan
    United States

    Site Not Available

  • St. Joseph, Michigan
    United States

    Site Not Available

  • Minneapolis, Minnesota
    United States

    Site Not Available

  • St. Cloud, Minnesota
    United States

    Site Not Available

  • St. Paul, Minnesota
    United States

    Site Not Available

  • Tupelo, Mississippi
    United States

    Site Not Available

  • St. Louis, Missouri
    United States

    Site Not Available

  • Hastings, Nebraska
    United States

    Site Not Available

  • Cherry Hill, New Jersey
    United States

    Site Not Available

  • Elmer, New Jersey
    United States

    Site Not Available

  • Albuquerque, New Mexico
    United States

    Site Not Available

  • Bronx, New York
    United States

    Site Not Available

  • East Syracuse, New York
    United States

    Site Not Available

  • Johnson City, New York
    United States

    Site Not Available

  • New Hyde Park, New York
    United States

    Site Not Available

  • Syracuse, New York
    United States

    Site Not Available

  • Charlotte, North Carolina
    United States

    Site Not Available

  • Durham, North Carolina
    United States

    Site Not Available

  • Gastonia, North Carolina
    United States

    Site Not Available

  • Bismarck, North Dakota
    United States

    Site Not Available

  • Cincinnati, Ohio
    United States

    Site Not Available

  • Kettering, Ohio
    United States

    Site Not Available

  • Mansfield, Ohio
    United States

    Site Not Available

  • Toledo, Ohio
    United States

    Site Not Available

  • Corvallis, Oregon
    United States

    Site Not Available

  • Salem, Oregon
    United States

    Site Not Available

  • Easton, Pennsylvania
    United States

    Site Not Available

  • Philadelphia, Pennsylvania
    United States

    Site Not Available

  • York, Pennsylvania
    United States

    Site Not Available

  • Cookville, Tennessee
    United States

    Site Not Available

  • Germantown, Tennessee
    United States

    Site Not Available

  • Nashville, Tennessee
    United States

    Site Not Available

  • Austin, Texas
    United States

    Site Not Available

  • Houston, Texas
    United States

    Site Not Available

  • Plano, Texas
    United States

    Site Not Available

  • Tyler, Texas
    United States

    Site Not Available

  • Richmond, Virginia
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.