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

February 26, 2008 updated by: Medtronic Cardiac Rhythm and Heart Failure

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1070

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver,, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Quebec
      • Sainte-Foy, Quebec, Canada
      • Trois Rivieres, Quebec, Canada
  • United States
    • Arizona
      • Phoenix, Arizona, United States
      • Scottsdale, Arizona, United States
    • Arkansas
      • Conway,, Arkansas, United States
    • California
      • Glendale, California, United States
      • La Mesa, California, United States
      • Santa Rosa, California, United States
    • Colorado
      • Boulder, Colorado, United States
      • Denver, Colorado, United States
    • Florida
      • 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
    • Georgia
      • Atlanta, Georgia, United States
      • Tifton,, Georgia, United States
    • Illinois
      • Maywood, Illinois, United States
      • Rockford, Illinois, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Louisiana
      • LaCombe, Louisiana, United States
    • Maryland
      • Annapolis, Maryland, United States
      • Salisbury, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Worcester, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Grand Rapids, Michigan, United States
      • Southfield, Michigan, United States
      • St. Joseph, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
      • St. Cloud, Minnesota, United States
      • St. Paul, Minnesota, United States
    • Mississippi
      • Tupelo, Mississippi, United States
    • Missouri
      • St. Louis, Missouri, United States
    • Nebraska
      • Hastings, Nebraska, United States
    • New Jersey
      • Cherry Hill, New Jersey, United States
      • Elmer, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Bronx, New York, 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
    • North Carolina
      • Charlotte, North Carolina, United States
      • Durham, North Carolina, United States
      • Gastonia, North Carolina, United States
    • North Dakota
      • Bismarck, North Dakota, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Kettering, Ohio, United States
      • Mansfield, Ohio, United States
      • Toledo, Ohio, United States
    • Oregon
      • Corvallis, Oregon, United States
      • Salem, Oregon, United States
    • Pennsylvania
      • Easton, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • York, Pennsylvania, United States
    • Tennessee
      • Cookville, Tennessee, United States
      • Germantown, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Houston, Texas, United States
      • Plano, Texas, United States
      • Tyler, Texas, United States
    • Virginia
      • Richmond, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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:
  • MVP
  • Medtronic
  • Search AV+
  • Search AV
  • Dual-Chamber Pacemaker
No Intervention: 2
conventional dual-chamber pacing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
from Jan 2003 to Dec 2006

Secondary Outcome Measures

Outcome Measure
Time Frame
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
from Jan 2003 to Dec 2006

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

January 31, 2006

First Submitted That Met QC Criteria

January 31, 2006

First Posted (Estimate)

February 1, 2006

Study Record Updates

Last Update Posted (Estimate)

February 29, 2008

Last Update Submitted That Met QC Criteria

February 26, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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