NCT00284830

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,070 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sick Sinus Syndrome
• Heart Failure, Congestive
• Atrial Fibrillation
• Bradycardia
• Ventricular Dysfunction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2003-01-01
• Primary completion: 2006-12-01
• Completion: 2008-02-01
• First posted: 2006-02-01
• Last updated: 2008-02-29

Locations

67 sites across 2 countries: United States, Canada