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

Duke University

Status: Completed

Conditions: Cardiomyopathy; Heart Failure

Treatments: Other: "Simultaneous Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343); Other: "Sequential Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00737490

Pro00007865

7314 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. LVEF </= 35% as assessed by echocardiography.
2. New York Heart Association Functional Class III or IV CHF despite contemporary medical therapy for CHF.
3. QRS duration of >/= 120 ms.
4. Ability to provide written, informed consent.
5. Age > 18 years.
6. Successful implant of a biventricular/ICD pacemaker device.

Exclusion criteria

1. Documented Chronic Atrial Fibrillation
2. Life expectancy less that 6 months due to non-cardiac causes
3. Inability to place a coronary sinus left ventricular pacing lead
4. Pregnancy
5. Scheduled cardiac surgery within the next 6 months
6. Prosthetic Tricuspid Valve

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

1

Active Comparator group

Description:

Echocardiographically guided optimized device programming: specifically sequential BiV pacing. "Sequential Arm"

Treatment:

Other: "Sequential Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)

2

Active Comparator group

Description:

Simultaneous BiV pacing. "Simultaneous Arm"

Treatment:

Other: "Simultaneous Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)