Real Time 3-Dimensional Echocardiography for Left Ventricular Lead Site Selection to Reduce Cardiac Resynchronization Therapy Non-Responder Rates
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/21/2019 |
| Start Date: | August 2010 |
Real Time 3-Dimensional Echocardiography for Left Ventricular Lead Site Selection to Reduce Cardiac Resynchronization Therapy Non-Responder Rates (ENVISION)
The purpose of this study is to demonstrate that cardiac resynchronization therapy (CRT)
responder rate can be improved by 3-dimensional (3D) echo-guided left ventricular (LV) lead
placement compared to traditional LV lead placement.
responder rate can be improved by 3-dimensional (3D) echo-guided left ventricular (LV) lead
placement compared to traditional LV lead placement.
Inclusion Criteria:
- Patients will be implanted with an FDA approved St. Jude Medical CRT-D device (i.e.
PROMOTE® or newer devices with similar functionality)
- Patients will have an approved indication per American College of Cardiology/American
Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D
- Patients will receive a new implant or an upgrade from an existing pacemaker or
Implantable Cardiovertor Defibrillator with no prior Left Ventricular lead placement
- Patients must be in sinus rhythm at the time of enrollment visit and baseline
measurements
Exclusion Criteria:
- Persistent or permanent atrial fibrillation
- Heart transplantation
- Recent myocardial infarction (< 90 days)
- Contra-indication to contrast agent
- Are less than 18 years of age
- Are pregnant
- Are currently participating in a clinical investigation that includes an active
treatment arm
- Have a life expectancy of less than 6 months
We found this trial at
1
site
Click here to add this to my saved trials
