Atrial Fibrillation Clinical Trial
— SAVEPACeOfficial title:
Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction (SAVE PACe)
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.
Status | Completed |
Enrollment | 1070 |
Est. completion date | February 2008 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Medtronic Cardiac Rhythm Disease Management |
United States, Canada,
Sweeney MO, Bank AJ, Nsah E, Koullick M, Zeng QC, Hettrick D, Sheldon T, Lamas GA; Search AV Extension and Managed Ventricular Pacing for Promoting Atrioventricular Conduction (SAVE PACe) Trial. Minimizing ventricular pacing to reduce atrial fibrillation — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | No |
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