SAVEPACe - Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction
NCT ID: NCT00284830
Last Updated: 2008-02-29
Study Results
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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COMPLETED
NA
1070 participants
INTERVENTIONAL
2003-01-31
2008-02-29
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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1
dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization
Implantable Pulse Generators
dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization
2
conventional dual-chamber pacing
No interventions assigned to this group
Interventions
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Implantable Pulse Generators
dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 minutes for a period of nine seconds while atrial pacing
Exclusion Criteria
* 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 limit study participation
* Enrolled or intend to participate in another clinical trial during the course of this study
* 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 to screen
* 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
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Medtronic CRDM Clinical Research
Principal Investigators
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Michael O. Sweeney, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Conway, Arkansas, United States
Glendale, California, United States
La Mesa, California, United States
Santa Rosa, California, United States
Boulder, Colorado, United States
Denver, Colorado, United States
Clearwater, Florida, United States
Ft. Pierce, Florida, United States
Lakeland, Florida, United States
Miami Beach, Florida, United States
Orlando, Florida, United States
Verro Beach, Florida, United States
Atlanta, Georgia, United States
Tifton, Georgia, United States
Maywood, Illinois, United States
Rockford, Illinois, United States
Lexington, Kentucky, United States
Lacombe, Louisiana, United States
Annapolis, Maryland, United States
Salisbury, Maryland, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Grand Rapids, Michigan, United States
Saint Joseph, Michigan, United States
Southfield, Michigan, United States
Minneapolis, Minnesota, United States
Saint Cloud, Minnesota, United States
Saint Paul, Minnesota, United States
Tupelo, Mississippi, United States
St Louis, Missouri, United States
Hastings, Nebraska, United States
Cherry Hill, New Jersey, United States
Elmer, New Jersey, United States
Albuquerque, New Mexico, United States
East Syracuse, New York, United States
Johnson City, New York, United States
New Hyde Park, New York, United States
Syracuse, New York, United States
The Bronx, New York, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Gastonia, North Carolina, United States
Bismarck, North Dakota, United States
Cincinnati, Ohio, United States
Kettering, Ohio, United States
Mansfield, Ohio, United States
Toledo, Ohio, United States
Corvallis, Oregon, United States
Salem, Oregon, United States
Easton, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
York, Pennsylvania, United States
Cookeville, Tennessee, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
Tyler, Texas, United States
Richmond, Virginia, United States
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Sainte-Foy, Quebec, Canada
Trois-Rivières, Quebec, Canada
Countries
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References
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Sweeney MO, Bank AJ, Nsah E, Koullick M, Zeng QC, Hettrick D, Sheldon T, Lamas GA; Search AV Extension and Managed Ventricular Pacing for Promoting Atrioventricular Conduction (SAVE PACe) Trial. Minimizing ventricular pacing to reduce atrial fibrillation in sinus-node disease. N Engl J Med. 2007 Sep 6;357(10):1000-8. doi: 10.1056/NEJMoa071880.
Other Identifiers
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191
Identifier Type: -
Identifier Source: org_study_id