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

Primary Purpose

Cardiomyopathy, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
"Sequential Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)
"Simultaneous Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiomyopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

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

Simultaneous BiV pacing. "Simultaneous Arm"

Outcomes

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.

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.

Full Information

First Posted
May 4, 2008
Last Updated
July 31, 2014
Sponsor
Duke University
Collaborators
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00737490
Brief Title
Does Echocardiographically Guided Ventriculo-Ventricular Optimization Yield a Sustained Improvement in Echocardiographic Parameters in Cardiac Resynchronization Therapy Patients? (DEVISE CRT)
Acronym
Devise-CRT
Official Title
Does Echocardiographically Guided Ventriculo-Ventricular Optimization Yield a Sustained Improvement in Echocardiographic Parameters in Cardiac Resynchronization Therapy Patients? (DEVISE CRT)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathy, Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Echocardiographically guided optimized device programming: specifically sequential BiV pacing. "Sequential Arm"
Arm Title
2
Arm Type
Active Comparator
Arm Description
Simultaneous BiV pacing. "Simultaneous Arm"
Intervention Type
Other
Intervention Name(s)
"Sequential Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)
Intervention Description
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
Intervention Name(s)
"Simultaneous Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)
Intervention Description
simultaneous BiV pacing. Using one of the FDA approved St. Jude devices, depending on MD preference.
Primary Outcome Measure Information:
Title
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Assessment for improvements in 1)6 minute walk 2)ECHO parameters 3)symptoms as assessed by the Minnesota Quality of Life Score.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hranitzky Patrick, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick Hranitzky, MD
Organizational Affiliation
Duke University
Official's Role
Study Director
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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