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

This study has been completed.
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00284830
First received: January 31, 2006
Last updated: February 26, 2008
Last verified: February 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Disease Management:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284830

  Show 67 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
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
Study First Received: January 31, 2006
Last Updated: February 26, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
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:
Sick Sinus Syndrome
Atrial Fibrillation
Heart Failure
Ventricular Dysfunction
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus
Heart Block

ClinicalTrials.gov processed this record on September 22, 2014