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

Medtronic

Status: Completed

Conditions: Bradycardia; Atrial Fibrillation; Ventricular Dysfunction; Heart Failure, Congestive; Sick Sinus Syndrome

Treatments: Device: Implantable Pulse Generators

Study type: Interventional

Funder types: Industry

Identifiers

NCT00284830

191

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,070 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,070 participants in 2 patient groups

1

Active Comparator group

Description:

dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization

Treatment:

Device: Implantable Pulse Generators

2

No Intervention group

Description:

conventional dual-chamber pacing