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

Sponsor:	Medtronic Cardiac Rhythm Disease Management
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00284830

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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Heart Failure

U.S. FDA Resources

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

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:

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.

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:

Atrial Fibrillation
Heart Failure
Sick Sinus Syndrome
Ventricular Dysfunction
Bradycardia
Arrhythmias, Cardiac

Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus
Heart Block

ClinicalTrials.gov processed this record on February 09, 2012