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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00284830
First Posted: February 1, 2006
Last Update Posted: February 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure
  Purpose
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 Intervention
Sick Sinus Syndrome Heart Failure, Congestive Atrial Fibrillation Bradycardia Ventricular Dysfunction Device: Implantable Pulse Generators

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm and Heart Failure:

Primary Outcome Measures:
  • 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 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. [ Time Frame: from Jan 2003 to Dec 2006 ]

Enrollment: 1070
Study Start Date: January 2003
Study Completion Date: February 2008
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284830


  Show 67 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
Principal Investigator: Michael O. Sweeney, MD Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Medtronic CRDM Clinical Research
ClinicalTrials.gov Identifier: NCT00284830     History of Changes
Other Study ID Numbers: 191
First Submitted: January 31, 2006
First Posted: February 1, 2006
Last Update Posted: February 29, 2008
Last Verified: February 2008

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
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
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Arrhythmia, Sinus
Heart Block