Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147290
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2005-09-06
Brief Title:
ADVANCE CRT - 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 CRT - 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-CRTD
Brief Summary:
To compare the efficacy of RV and BiV ATP for the termination of ventricular arrhythmias in patients who are candidates to a cardiac resynchronisation therapy CRT and have a Class I or IIA indication for ICD implantation
The hypothesis of delivering ATP from different sites RV or BIV has never been evaluated in a prospective controlled and randomized study
The hypothesis of delivering ATP from different sites RV or BIV has never been evaluated in a prospective controlled and randomized study
Detailed Description:
Main objective Compare efficacy of ATP therapy Burst 8 pulses 88 1 sequence to terminate all types of ventricular tachycardia all VTs FVTVT when delivered in the right ventricle RV only versus both ventricles BiV resulting in a 10 difference in favour of BIV ATP
Secondary objectives
Compare efficacy of the first BiV and RV ATP Burst 8 pulses 88 to terminate fast ventricular tachycardia FVT
Compare efficacy of the first BiV and RV ATP Burst 8 pulses 88 to terminate slow ventricular tachycardia slow VT
Compare efficacy of BiV and RV ATP all ATP therapies to terminate slow ventricular tachycardia slow VT
Determine the rate of both FVT and VT episodes which are accelerated or degenerates into VF
Secondary objectives
Compare efficacy of the first BiV and RV ATP Burst 8 pulses 88 to terminate fast ventricular tachycardia FVT
Compare efficacy of the first BiV and RV ATP Burst 8 pulses 88 to terminate slow ventricular tachycardia slow VT
Compare efficacy of BiV and RV ATP all ATP therapies to terminate slow ventricular tachycardia slow VT
Determine the rate of both FVT and VT episodes which are accelerated or degenerates into VF
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