Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00170287
Status:
COMPLETED
Last Update Posted:
2017-09-06
First Post:
2005-09-09
Brief Title:
SMS Substrate Modification Study in Patients Getting an Implantable Cardioverter Defibrillator ICD
Sponsor:
Medtronic Bakken Research Center
Organization:
Medtronic Bakken Research Center
Study Overview
Official Title:
Substrate Modification Study in Patients Getting an ICD
Status:
COMPLETED
Status Verified Date:
2017-09
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:
SMS
Brief Summary:
The present standard of care for the management of unstable ventricular tachycardia VT in the setting of chronic coronary artery disease is the placement of an implantable cardioverter defibrillator ICD after the initial episode and radiofrequency ablation andor antiarrhythmic medication in the event of recurrences causing frequent ICD interventions
The primary purpose of this randomized study is the assessment of recurrences of unstable VT in patients who undergo ICD implantation plus substrate ablation after the initial episode compared to patients who only undergo ICD implantation Thus the primary purpose is an improvement in the quality of life A decrease in mortality is not a primary purpose of this study
The primary purpose of this randomized study is the assessment of recurrences of unstable VT in patients who undergo ICD implantation plus substrate ablation after the initial episode compared to patients who only undergo ICD implantation Thus the primary purpose is an improvement in the quality of life A decrease in mortality is not a primary purpose of this study
Detailed Description:
None
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