Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147277
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2005-09-06
Brief Title:
ADVANCE-D Antitachycardia Pacing ATP Delivery for Painless Implantable Cardioverter Defibrillator ICD Therapy
Sponsor:
Medtronic Bakken Research Center
Organization:
Medtronic Bakken Research Center
Study Overview
Official Title:
ADVANCE-D ATP Delivery for Painless ICD Therapy
Status:
COMPLETED
Status Verified Date:
2015-08
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:
ADVANCE_D
Brief Summary:
The purpose of this study is to estimate and quantify the difference in efficacy of two sequences of ATP therapies burst 15 pulses 88 versus burst 8 pulses 88 during an episode of spontaneous rhythms classified as fast ventricular tachycardia FVT via ventricular fibrillation VF in patients who have a Class I or II A indication for ICD implantation and thus to promote the painless therapy aspect of ICD treatment and improve quality of life outcomes for patients
Detailed Description:
Main objective Compare quantify efficacy of two different sequences of burst ATP strategies for the termination of ventricular tachycardia with Cycle Lenght CL of 240ms-320ms from baseline to 12 months post randomisation in patients who are treated with ATP -8 pulses 88 versus patients who are treated with ATP -15 pulses 88
Secondary objectives
Estimate the efficacy of ATP in successfully treating FVT episodes for patients in primary and secondary prevention
Estimate acceleration rate or degeneration of ATP therapy for treating spontaneous FVT episodes in the ATP 15 vs 8 arm
Compare the likelihood of syncopal events associated with spontaneous FVT episodes
Estimate the percent reduction in number of shocks delivered per patient for treating spontaneous FVT episodes
Evaluate different possible predictors of ATP success VT rate underlying disease Anti-Arrhythmic Drugs AAD infarct zone etc
Secondary objectives
Estimate the efficacy of ATP in successfully treating FVT episodes for patients in primary and secondary prevention
Estimate acceleration rate or degeneration of ATP therapy for treating spontaneous FVT episodes in the ATP 15 vs 8 arm
Compare the likelihood of syncopal events associated with spontaneous FVT episodes
Estimate the percent reduction in number of shocks delivered per patient for treating spontaneous FVT episodes
Evaluate different possible predictors of ATP success VT rate underlying disease Anti-Arrhythmic Drugs AAD infarct zone etc
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