Does Echocardiographically Guided Ventriculo-Ventricular Optimization Yield a Sustained Improvement in Echocardiographic Parameters in Cardiac Resynchronization Therapy Patients? (DEVISE CRT)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether using an echocardiogram (a painless test where ultrasound is used to see your heart) while using mild electrical stimulation from your own CRT-D device to stimulate the ventricles (the lower chambers of the heart) to squeeze one slightly earlier than the other will show a sustained increase your heart's productivity (Cardiac Output (CO)), following implantation of a Cardiac Resynchronization Device (CRT-D). We believe that squeezing some parts of the heart earlier than others may make the heart a stronger pump.

Official Title
-----------------
Does Echocardiographically Guided Ventriculo-Ventricular Optimization Yield a Sustained Improvement in Echocardiographic Parameters in Cardiac Resynchronization Therapy Patients? (DEVISE CRT)

Conditions
-----------------
Cardiomyopathy, Heart Failure

Intervention / Treatment
-----------------
* Other: Sequential Arm (Promote , model # 2207-36 or Atlas HF , model # V-343)
* Other: Simultaneous Arm (Promote , model # 2207-36 or Atlas HF , model # V-343)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: LVEF </= 35% as assessed by echocardiography. New York Heart Association Functional Class III or IV CHF despite contemporary medical therapy for CHF. QRS duration of >/= 120 ms. Ability to provide written, informed consent. Age > 18 years. Successful implant of a biventricular/ICD pacemaker device. Exclusion Criteria: Documented Chronic Atrial Fibrillation Life expectancy less that 6 months due to non-cardiac causes Inability to place a coronary sinus left ventricular pacing lead Pregnancy Scheduled cardiac surgery within the next 6 months Prosthetic Tricuspid Valve

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Echocardiographically guided optimized device programming: specifically sequential BiV pacing. Sequential Arm | Other: Sequential Arm (Promote , model # 2207-36 or Atlas HF , model # V-343)<br>* Echocardiographically guided optimized device programming: specifically sequential BiV pacing. Sequential Arm Using one of the FDA approved St. Jude devices, depending on MD preference.<br>|
| Active Comparator: 2<br>Simultaneous BiV pacing. Simultaneous Arm | Other: Simultaneous Arm (Promote , model # 2207-36 or Atlas HF , model # V-343)<br>* simultaneous BiV pacing. Using one of the FDA approved St. Jude devices, depending on MD preference.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if a sustained hemodynamic benefit of increased Cardiac Output is maintained in patients who undergo ECHO guided optimization of V-V timing following CRT implantation when compared to patients simultaneously biventricularly paced. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment for improvements in 1)6 minute walk 2)ECHO parameters 3)symptoms as assessed by the Minnesota Quality of Life Score. |  | 6 months |