Status:
COMPLETED
SAVEPACe - Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Sick Sinus Syndrome
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 increa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
1070 Patients enrolled
Trial Details
Trial ID
NCT00284830
Start Date
January 1 2003
End Date
February 1 2008
Last Update
February 29 2008
Active Locations (67)
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Phoenix, Arizona, United States
2
Scottsdale, Arizona, United States
3
Conway, Arkansas, United States
4
Glendale, California, United States