Ignite Creation Date:
2024-05-05 @ 9:23 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00874445
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2009-03-31
Brief Title:
Comparison of 50 Tilt and Tuned Waveforms in Single-Coil Active Can Configuration
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
Prospective Comparison of 5050 Tilt and Tuned Defibrillation Waveforms in a Single Coil Active Can Configuration
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMISE
Brief Summary:
The purpose of this study is to compare the defibrillation efficacy between the 5050 tilt biphasic waveform and the Tuned biphasic waveform in a single coil active can configuration
Detailed Description:
There has been one prospective study that found some benefit of using tuned waveforms over 5050 tilt waveforms11 Other studies have failed to show much change in defibrillation efficacy with different duration biphasic waveforms A vast majority of patients in these studies were tested with dual coil leads Although dual coil leads can lower defibrillation thresholds it is known that dual coil leads can make the lead extraction difficult lead to venous obstruction and are more prone to failure Results from a recent study showed that that a single coil configuration is adequate in a vast majority of patients when DFT testing was performed with tuned waveforms This makes the use of single-coil leads during ICD CRT-D implants an attractive option
Theoretical analysis has shown that difference between the tuned and 50 tilt waveforms is amplified at high impedance levels with tuned waveforms being superior unpublished Accordingly this study has been designed to prospectively compare the DFT estimates with tuned and 50 tilt waveforms in left-sided active pectoral defibrillation lead systems when the SVC coil has been turned OFF or is not part of the shocking circuit
Theoretical analysis has shown that difference between the tuned and 50 tilt waveforms is amplified at high impedance levels with tuned waveforms being superior unpublished Accordingly this study has been designed to prospectively compare the DFT estimates with tuned and 50 tilt waveforms in left-sided active pectoral defibrillation lead systems when the SVC coil has been turned OFF or is not part of the shocking circuit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None