Right Ventricular Defibrillation Lead Select Site Study
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/2/2016 |
| Start Date: | October 2006 |
| End Date: | December 2008 |
| Contact: | Michael A Lincoln, MD |
| Email: | mlincoln@associatesincardiology.com |
| Phone: | 301-681-5700 |
This study will compare single coil right ventricular defibrillation leads for implanted
cardioverter/defibrillators (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 thresholds(DFTs), and that they may have long term
advantages in reducing left ventricular dysfunction.
cardioverter/defibrillators (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 thresholds(DFTs), and that they may have long term
advantages in reducing left ventricular dysfunction.
The new studies "Right Ventricular Lead/Select Site Registry" and "Right Ventricular
Lead/Select 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.
Lead/Select 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.
Inclusion Criteria:
- Standard indications for ICD placement (AHA/ACC guidelines)
Exclusion Criteria:
- Inability to consent
- age less than 21 years
- inability to participate in study follow-up
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