Ignite Creation Date:
2024-05-06 @ 8:52 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02844127
Status:
WITHDRAWN
Last Update Posted:
2017-09-19
First Post:
2016-07-08
Brief Title:
Effect of Right Ventricular Lead Position on Defibrillation Threshold
Sponsor:
OhioHealth
Organization:
OhioHealth
Study Overview
Official Title:
Effect of Right Ventricular Lead Position on Defibrillation Threshold
Status:
WITHDRAWN
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Devices proposed for use in the protocol no longer used by physician
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine how the position of the right ventricular RV coil of an implantable cardioverter defibrillator apex versus septum affects the defibrillation threshold specifically can defibrillator threshold be improved by implantation site selection
Detailed Description:
The investigators propose a prospective pseudo-randomized study of patients who are electing to undergo implantation of an implantable cardioverter defibrillator ICD
There are two locations in the heart in which ICDs are normally implanted the apex and the septum The purpose of this study is to determine whether the ICD performs better in one location or the other as measured by defibrillation threshold In this study both locations will be tested in each patient The final location will be determined by the implanting physician as the location that is best for the patient
There are two locations in the heart in which ICDs are normally implanted the apex and the septum The purpose of this study is to determine whether the ICD performs better in one location or the other as measured by defibrillation threshold In this study both locations will be tested in each patient The final location will be determined by the implanting physician as the location that is best for the patient
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