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

Heart Failure Clinical Trial

— Devise-CRT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737490
• Other study ID #: Pro00007865
• Secondary ID: 7314
• Status: Completed
• Phase: N/A
• First received: May 4, 2008
• Last updated: July 31, 2014
• Start date: June 2005
• Est. completion date: July 2011

Study information

• Verified date: April 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Heart Failure

Intervention

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.
• "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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	St. Jude Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Assessment for improvements in 1)6 minute walk 2)ECHO parameters 3)symptoms as assessed by the Minnesota Quality of Life Score.		6 months	No