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

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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.


Inclusion Criteria:

- Patients will be implanted with an FDA approved St. Jude Medical CRT-D device (i.e.
PROMOTEĀ® 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
Nashville, Tennessee
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from
Nashville, TN
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