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

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT00284830

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

1070

Starts

2003-01-01

Expected to finish

2008-02-01

Last updated by the study team

2008-02-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Conway, Arkansas, United States
• Study site — Glendale, California, United States
• Study site — La Mesa, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Boulder, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Clearwater, Florida, United States
• Study site — Ft. Pierce, Florida, United States
• Study site — Lakeland, Florida, United States
• Study site — Miami Beach, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Verro Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Tifton, Georgia, United States
• Study site — Maywood, Illinois, United States
• Study site — Rockford, Illinois, United States
• Study site — Lexington, Kentucky, United States
• Study site — Lacombe, Louisiana, United States
• Study site — Annapolis, Maryland, United States
• Study site — Salisbury, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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