Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399412
Status:
COMPLETED
Last Update Posted:
2017-02-16
First Post:
2006-11-10
Brief Title:
ECG Signal Collection From Long QT Syndrome Wide QRS Complexes Heart Failure and Cardiac Resynchronization Patients
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
Further Research on Human Feasibility of a Subcutaneous Implantable Defibrillator S-ICD- ECG Signal Collections From Various Patient Groups Whilst Attending Outpatient Follow-up
Status:
COMPLETED
Status Verified Date:
2009-10
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 purpose of this study is to collect surface electrograms from standard and several non-standard configurations in patients with long QT syndrome heart failure cardiac resynchronization therapy or wide QRS during a routine outpatient assessment The ECGs collected will be used as test signals by the sponsor for the development of a subcutaneous implantable defibrillator
Detailed Description:
The objective of this study is to record standard ECG signals is each of the 4 patient populations together with signals from 4 non-standard surface positions when these patients attend the outpatient department for follow-up The non-standard electrode positions mimic the positions of the subcutaneous electrodes of the subcutaneous implantable defibrillator S-ICD system in development by Cameron Health
The collection of these signals will allow bench testing of the algorithms proposed for the S-ICD system Additionally it will allow a comparison of the response of different defibrillators to these same signals to asses how each would treat a particular rhythm
The collection of these signals will allow bench testing of the algorithms proposed for the S-ICD system Additionally it will allow a comparison of the response of different defibrillators to these same signals to asses how each would treat a particular rhythm
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