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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Implantable Pulse Generators


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization | Device: Implantable Pulse Generators<br>* dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization<br>* Other names: Dual-Chamber Pacemaker;|
| No Intervention: 2<br>conventional dual-chamber pacing | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Right Ventricular Pacing, Persistent Atrial Fibrillation, Atrioventricular Conduction, Heart Failure Hospitalization, Cardiovascular Health Care Utilization, Sinus-node Disease, Minimized Ventricular Pacing