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

Primary Purpose

Sick Sinus Syndrome, Heart Failure, Congestive, Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Implantable Pulse Generators
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sick Sinus Syndrome focused on measuring Right Ventricular Pacing, Persistent Atrial Fibrillation, Atrioventricular Conduction, Heart Failure Hospitalization, Cardiovascular Health Care Utilization, Sinus-node Disease, Minimized Ventricular Pacing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 minutes for a period of nine seconds while atrial pacing 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 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1

2

Arm Description

dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization

conventional dual-chamber pacing

Outcomes

Primary Outcome Measures

To compare the time to development of persistent AF between all randomized subjects in the ON and OFF arms.

Secondary Outcome Measures

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.

Full Information

First Posted
January 31, 2006
Last Updated
February 26, 2008
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT00284830
Brief Title
SAVEPACe - Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction
Acronym
SAVEPACe
Official Title
Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction (SAVE PACe)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sick Sinus Syndrome, Heart Failure, Congestive, Atrial Fibrillation, Bradycardia, Ventricular Dysfunction
Keywords
Right Ventricular Pacing, Persistent Atrial Fibrillation, Atrioventricular Conduction, Heart Failure Hospitalization, Cardiovascular Health Care Utilization, Sinus-node Disease, Minimized Ventricular Pacing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1070 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization
Arm Title
2
Arm Type
No Intervention
Arm Description
conventional dual-chamber pacing
Intervention Type
Device
Intervention Name(s)
Implantable Pulse Generators
Other Intervention Name(s)
Search AV+, Search AV, MVP, Medtronic, Dual-Chamber Pacemaker
Intervention Description
dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization
Primary Outcome Measure Information:
Title
To compare the time to development of persistent AF between all randomized subjects in the ON and OFF arms.
Time Frame
from Jan 2003 to Dec 2006
Secondary Outcome Measure Information:
Title
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.
Time Frame
from Jan 2003 to Dec 2006

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 minutes for a period of nine seconds while atrial pacing 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael O. Sweeney, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
City
Phoenix
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Arizona
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United States
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Scottsdale
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Conway,
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Glendale
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La Mesa
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Santa Rosa
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Boulder
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Denver
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Clearwater
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Ft Pierce
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Lakeland
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Miami Beach
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Orlando
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Verro Beach
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Atlanta
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Tifton,
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Maywood
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Rockford
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Lexington
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LaCombe
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Annapolis
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Salisbury
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Boston
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Worcester
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Ann Arbor
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Grand Rapids
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Southfield
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St. Joseph
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Minneapolis
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St. Cloud
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St. Paul
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Tupelo
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St. Louis
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Hastings
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Cherry Hill
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Elmer
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Albuquerque
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New Mexico
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Bronx
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East Syracuse
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New York
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Johnson City
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New York
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New Hyde Park
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New York
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Syracuse
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New York
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Charlotte
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North Carolina
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Durham
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Gastonia
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Bismarck
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Cincinnati
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Kettering
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Ohio
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Mansfield
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Ohio
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Toledo
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Corvallis
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Salem
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Easton
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Philadelphia
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York
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Cookville
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Germantown
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Nashville
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Austin
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Houston
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Plano
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Tyler
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Richmond
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Virginia
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Vancouver,
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Winnipeg
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Manitoba
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Sainte-Foy
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Quebec
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Canada
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Trois Rivieres
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Quebec
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Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17804844
Citation
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.
Results Reference
result

Learn more about this trial

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

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