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

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT00737490

Collaborator

Abbott Medical Devices (Industry)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiomyopathy Heart Failure	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)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jun 1, 2005

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Echocardiographically guided optimized device programming: specifically sequential BiV pacing. "Sequential Arm"	Other: "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.
Active Comparator: 2 Simultaneous BiV pacing. "Simultaneous Arm"	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.

Arm

Intervention/Treatment

Active Comparator: 1

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

Other: "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.

Active Comparator: 2

Simultaneous BiV pacing. "Simultaneous Arm"

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

Duke University
Abbott Medical Devices

Investigators

Principal Investigator: Hranitzky Patrick, MD, Duke University
Study Director: Patrick Hranitzky, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Duke University

ClinicalTrials.gov Identifier:

NCT00737490

Other Study ID Numbers:

Pro00007865
7314

First Posted:

Aug 19, 2008

Last Update Posted:

Aug 1, 2014

Last Verified:

Apr 1, 2013

Additional relevant MeSH terms:

Cardiomyopathies

Study Results

No Results Posted as of Aug 1, 2014