Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00180349
Status:
COMPLETED
Last Update Posted:
2017-04-14
First Post:
2005-09-12
Brief Title:
Leader - Evaluation of Endotak Reliance
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
Short and Long Term Evaluation of Electrical Measurements and Defibrillation Energies Results of ATP and Diagnostic Functions of Devices Connected to Endotak RELIANCE Defibrillation Leads
Status:
COMPLETED
Status Verified Date:
2017-04
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:
None
Brief Summary:
The objective of this study is to demonstrate the efficacy of the ENDOTAK RELIANCE defibrillation leads connected to a defibrillator or a cardiac resynchronization defibrillator from implant until 12 months
Detailed Description:
Baseline and clinical data were collected at inclusion as were data on procedural characteristics device implantation-related adverse events and device programming at the time of hospital discharge Patients were subsequently divided in two groups patients who underwent VF induction at implantation or before hospital dischargeVF induction group and patients who did not undergo VF induction untested groupThe patients were followed up at 3-6 months and at12 months after the implantation VF induction procedures were left to the investigators discretion but reasons for not performing a VF induction at implantation were recorded prospectively ICD programming parameters for tachycardia or bradycardia were also left at the investigators discretion
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