Clinical trial NCT00284830: SAVEPACe - Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction
Official title: Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction (SAVE PACe)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sick Sinus Syndrome
Heart Failure, Congestive
Atrial Fibrillation
Bradycardia
Ventricular Dysfunction
Keywords: Right Ventricular Pacing
Persistent Atrial Fibrillation
Atrioventricular Conduction
Heart Failure Hospitalization
Cardiovascular Health Care Utilization
Sinus-node Disease
Minimized Ventricular Pacing
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2006-02-01
Enrollment: 1070
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: To compare the time to development of persistent AF between all randomized subjects in the ON and OFF arms.
timeFrame: from Jan 2003 to Dec 2006
Secondary outcomes:
measure: 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.
timeFrame: from Jan 2003 to Dec 2006
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Conway,
country: United States
state: Arkansas
city: Glendale
country: United States
state: California
city: La Mesa
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Clearwater
country: United States
state: Florida
city: Ft Pierce
country: United States
state: Florida
city: Lakeland
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Verro Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Tifton,
country: United States
state: Georgia
city: Maywood
country: United States
state: Illinois
city: Rockford
country: United States
state: Illinois
city: Lexington
country: United States
state: Kentucky
city: LaCombe
country: United States
state: Louisiana
city: Annapolis
country: United States
state: Maryland
city: Salisbury
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: St. Joseph
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: St. Cloud
country: United States
state: Minnesota
city: St. Paul
country: United States
state: Minnesota
city: Tupelo
country: United States
state: Mississippi
city: St. Louis
country: United States
state: Missouri
city: Hastings
country: United States
state: Nebraska
city: Cherry Hill
country: United States
state: New Jersey
city: Elmer
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Bronx
country: United States
state: New York
city: East Syracuse
country: United States
state: New York
city: Johnson City
country: United States
state: New York
city: New Hyde Park
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Gastonia
country: United States
state: North Carolina
city: Bismarck
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Mansfield
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Corvallis
country: United States
state: Oregon
city: Salem
country: United States
state: Oregon
city: Easton
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: York
country: United States
state: Pennsylvania
city: Cookville
country: United States
state: Tennessee
city: Germantown
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Vancouver,
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Sainte-Foy
country: Canada
state: Quebec
city: Trois Rivieres
country: Canada
state: Quebec
Study officials:
affiliation: Brigham and Women's Hospital
name: Michael O. Sweeney, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1056/NEJMoa071880.