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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,070
dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization
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
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
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Conway, Arkansas, United States
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Glendale, California, United States
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La Mesa, California, United States
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Santa Rosa, California, United States
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Boulder, Colorado, United States
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Denver, Colorado, United States
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Clearwater, Florida, United States
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Ft. Pierce, Florida, United States
...and 57 more locations