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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiomyopathy Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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

Using one of the FDA approved St. Jude devices, depending on MD preference.

2

Simultaneous BiV pacing. "Simultaneous Arm"

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

simultaneous BiV pacing.

Using one of the FDA approved St. Jude devices, depending on MD preference.

Interventions

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

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

Using one of the FDA approved St. Jude devices, depending on MD preference.

Intervention Type OTHER

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

simultaneous BiV pacing.

Using one of the FDA approved St. Jude devices, depending on MD preference.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No