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

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.

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Key information

Conditions

Sick Sinus Syndrome Arrhythmia, Sinus Arrhythmias, Cardiac Atrial Fibrillation Bradycardia Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Heart Failure Heart Failure, Congestive Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vancouver, British Columbia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantable Pulse Generators

Device

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

Other names: Search AV+, Search AV, MVP, Medtronic, Dual-Chamber Pacemaker

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

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

Acronym: SAVEPACe

Important dates

Study start: 2003
Primary completion: 2006
Study completion: 2008
First posted: Feb 1, 2006
Registry last updated: Feb 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed