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

Sponsor
Medtronic Cardiac Rhythm and Heart Failure (Industry)
Overall Status
Completed
CT.gov ID
NCT00284830
Collaborator
(none)
1,070
Enrollment
67
Locations
2
Arms
61
Duration (Months)
16
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Implantable Pulse Generators
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1070 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction (SAVE PACe)
Study Start Date :
Jan 1, 2003
Actual Primary Completion Date :
Dec 1, 2006
Actual Study Completion Date :
Feb 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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

Device: 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 Names:
  • Search AV+
  • Search AV
  • MVP
  • Medtronic
  • Dual-Chamber Pacemaker

    		•
    No Intervention: 2

    conventional dual-chamber pacing

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Phoenix Arizona United States
    2 Scottsdale Arizona United States
    3 Conway, Arkansas United States
    4 Glendale California United States
    5 La Mesa California United States
    6 Santa Rosa California United States
    7 Boulder Colorado United States
    8 Denver Colorado United States
    9 Clearwater Florida United States
    10 Ft Pierce Florida United States
    11 Lakeland Florida United States
    12 Miami Beach Florida United States
    13 Orlando Florida United States
    14 Verro Beach Florida United States
    15 Atlanta Georgia United States
    16 Tifton, Georgia United States
    17 Maywood Illinois United States
    18 Rockford Illinois United States
    19 Lexington Kentucky United States
    20 LaCombe Louisiana United States
    21 Annapolis Maryland United States
    22 Salisbury Maryland United States
    23 Boston Massachusetts United States
    24 Worcester Massachusetts United States
    25 Ann Arbor Michigan United States
    26 Grand Rapids Michigan United States
    27 Southfield Michigan United States
    28 St. Joseph Michigan United States
    29 Minneapolis Minnesota United States
    30 St. Cloud Minnesota United States
    31 St. Paul Minnesota United States
    32 Tupelo Mississippi United States
    33 St. Louis Missouri United States
    34 Hastings Nebraska United States
    35 Cherry Hill New Jersey United States
    36 Elmer New Jersey United States
    37 Albuquerque New Mexico United States
    38 Bronx New York United States
    39 East Syracuse New York United States
    40 Johnson City New York United States
    41 New Hyde Park New York United States
    42 Syracuse New York United States
    43 Charlotte North Carolina United States
    44 Durham North Carolina United States
    45 Gastonia North Carolina United States
    46 Bismarck North Dakota United States
    47 Cincinnati Ohio United States
    48 Kettering Ohio United States
    49 Mansfield Ohio United States
    50 Toledo Ohio United States
    51 Corvallis Oregon United States
    52 Salem Oregon United States
    53 Easton Pennsylvania United States
    54 Philadelphia Pennsylvania United States
    55 York Pennsylvania United States
    56 Cookville Tennessee United States
    57 Germantown Tennessee United States
    58 Nashville Tennessee United States
    59 Austin Texas United States
    60 Houston Texas United States
    61 Plano Texas United States
    62 Tyler Texas United States
    63 Richmond Virginia United States
    64 Vancouver, British Columbia Canada
    65 Winnipeg Manitoba Canada
    66 Sainte-Foy Quebec Canada
    67 Trois Rivieres Quebec Canada

    Sponsors and Collaborators

    • Medtronic Cardiac Rhythm and Heart Failure

    Investigators

    • Principal Investigator: Michael O. Sweeney, MD, Brigham and Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00284830
    Other Study ID Numbers:
    • 191
    First Posted:
    Feb 1, 2006
    Last Update Posted:
    Feb 29, 2008
    Last Verified:
    Feb 1, 2008
    Keywords provided by , ,
    Right Ventricular Pacing
    Persistent Atrial Fibrillation
    Atrioventricular Conduction
    Heart Failure Hospitalization
    Cardiovascular Health Care Utilization
    Sinus-node Disease
    Minimized Ventricular Pacing
    Additional relevant MeSH terms:
    Heart Failure
    Atrial Fibrillation
    Ventricular Dysfunction
    Bradycardia
    Sick Sinus Syndrome

    Study Results

    No Results Posted as of Feb 29, 2008