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

NCT00737490 | Completed

• 2 other identifiers: Pro000078657314
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathy; Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  6 months

Study Arms (2)

1

ACTIVE COMPARATOR

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

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

2

ACTIVE COMPARATOR

Simultaneous BiV pacing. "Simultaneous Arm"

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

Interventions

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

1

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

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Abbott Medical Devices: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Cardiomyopathies; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Hranitzky Patrick, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Patrick Hranitzky, MD

  Duke University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2008
• First Posted: August 19, 2008
• Study Start: June 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2011
• Last Updated: August 1, 2014

Record last verified: 2013-04

Locations

US (1)