SAVEPACe - Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction
SAVEPACe
Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction (SAVE PACe)
1 other identifier
interventional
1,070
2 countries
67
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2003
Longer than P75 for not_applicable
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 31, 2006
CompletedFirst Posted
Study publicly available on registry
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFebruary 29, 2008
February 1, 2008
3.9 years
January 31, 2006
February 26, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the time to development of persistent AF between all randomized subjects in the ON and OFF arms.
from Jan 2003 to Dec 2006
Secondary Outcomes (1)
To compare composite endpoint of AF and heart failure hospitalization (HFH), HFH, cardiovascular health care utilization, symptoms, HF medications, cumulative %, adverse events and incidence of stroke between the arms.
from Jan 2003 to Dec 2006
Study Arms (2)
1
ACTIVE COMPARATORdual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization
2
NO INTERVENTIONconventional dual-chamber pacing
Interventions
dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization
Eligibility Criteria
You may qualify if:
- 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 minutes for a period of nine seconds while atrial pacing
You may not qualify if:
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Scottsdale, Arizona, United States
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Conway, Arkansas, United States
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Glendale, California, United States
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La Mesa, California, United States
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Santa Rosa, California, United States
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Boulder, Colorado, United States
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Denver, Colorado, United States
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Clearwater, Florida, United States
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Ft. Pierce, Florida, United States
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Lakeland, Florida, United States
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Miami Beach, Florida, United States
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Orlando, Florida, United States
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Verro Beach, Florida, United States
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Atlanta, Georgia, United States
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Tifton, Georgia, United States
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Maywood, Illinois, United States
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Rockford, Illinois, United States
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Lexington, Kentucky, United States
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Lacombe, Louisiana, United States
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Annapolis, Maryland, United States
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Salisbury, Maryland, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Grand Rapids, Michigan, United States
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Saint Joseph, Michigan, United States
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Southfield, Michigan, United States
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Minneapolis, Minnesota, United States
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Saint Cloud, Minnesota, United States
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Saint Paul, Minnesota, United States
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Tupelo, Mississippi, United States
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St Louis, Missouri, United States
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Hastings, Nebraska, United States
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Cherry Hill, New Jersey, United States
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Elmer, New Jersey, United States
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Albuquerque, New Mexico, United States
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East Syracuse, New York, United States
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Johnson City, New York, United States
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New Hyde Park, New York, United States
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Syracuse, New York, United States
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The Bronx, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Gastonia, North Carolina, United States
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Bismarck, North Dakota, United States
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Cincinnati, Ohio, United States
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Kettering, Ohio, United States
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Mansfield, Ohio, United States
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Toledo, Ohio, United States
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Corvallis, Oregon, United States
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Salem, Oregon, United States
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Easton, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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York, Pennsylvania, United States
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Cookeville, Tennessee, United States
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Germantown, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Houston, Texas, United States
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Plano, Texas, United States
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Tyler, Texas, United States
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Richmond, Virginia, United States
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Sainte-Foy, Quebec, Canada
Unknown Facility
Trois-Rivières, Quebec, Canada
Related Publications (1)
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.
PMID: 17804844RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael O. Sweeney, MD
Brigham and Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 31, 2006
First Posted
February 1, 2006
Study Start
January 1, 2003
Primary Completion
December 1, 2006
Study Completion
February 1, 2008
Last Updated
February 29, 2008
Record last verified: 2008-02