Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385749
Status:
UNKNOWN
Last Update Posted:
2007-11-01
First Post:
2006-10-10
Brief Title:
Right Ventricular Defibrillation Lead Select Site Study
Sponsor:
Associates in Cardiology PA
Organization:
Associates in Cardiology PA
Study Overview
Official Title:
Right Ventricular Defibrillation Lead Select Site Study
Status:
UNKNOWN
Status Verified Date:
2007-10
Last Known Status:
RECRUITING
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:
This study will compare single coil right ventricular defibrillation leads for implanted cardioverterdefibrillators ICDs in the apical and high septal locations It is hypothesized that RV septal positions are at least as good as apical positions using formally measured defibrillation thresholdsDFTs and that they may have long term advantages in reducing left ventricular dysfunction
Detailed Description:
The new studies Right Ventricular LeadSelect Site Registry and Right Ventricular LeadSelect Site Registry Acute Study are studies designed to look at alternate lead locations for defibrillation leads for ICDs The registry is designed to capture data from patients who have already undergone implant so as to be able to publish long term data on defibrillation thresholds pacing thresholds and left ventricular function This will include both patients from the acute study and those patients in whom leads have already been placed and the exact lead location is known The acute study is designed to directly compare defibrillation thresholds in the apical location versus the interventricular septal location for defibrillation leads This study involves a direct comparison of two different sites in the same patient using defined criteria for implant location see protocol The acute study is anticipated to enroll 34 patients but the registry to collect ongoing data will be larger encompassing previously implanted patients with an expected sample size of 61 total in the registry for data collection
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