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

Not Applicable

Completed

• Conditions: Heart Failure; Cardiomyopathy
• Interventions: 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)

• Registration Number: NCT00737490
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2008-05-04
• Study First Submitted QC: 2008-08-18
• Study First Posted: 2008-08-19
• Primary Completion: 2009-12
• Study Completion: 2011-07
• Status Verified: 2013-04
• Last Update Submitted: 2014-07-31
• Last Update Posted: 2014-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	"Simultaneous Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)	Simultaneous BiV pacing. "Simultaneous Arm"
1	"Sequential Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)	Echocardiographically guided optimized device programming: specifically sequential BiV pacing. "Sequential Arm"

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Assessment for improvements in 1)6 minute walk 2)ECHO parameters 3)symptoms as assessed by the Minnesota Quality of Life Score.	6 months

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States