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

Not Applicable

Completed

• Conditions: Sick Sinus Syndrome; Heart Failure, Congestive; Atrial Fibrillation; Bradycardia; Ventricular Dysfunction
• Interventions: Device: Implantable Pulse Generators

• Registration Number: NCT00284830
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2006-01-31
• Study First Submitted QC: 2006-01-31
• Study First Posted: 2006-02-01
• Primary Completion: 2006-12
• Status Verified: 2008-02
• Study Completion: 2008-02
• Last Update Submitted: 2008-02-26
• Last Update Posted: 2008-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1070

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	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

Primary Outcome Measures

Name	Time	Method
To compare the time to development of persistent AF between all randomized subjects in the ON and OFF arms.	from Jan 2003 to Dec 2006

Secondary Outcome Measures

Name	Time	Method
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.	from Jan 2003 to Dec 2006