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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00737490

Acronym

Devise-CRT

Enrollment

Registered

2008-08-19

Start date

2005-06-30

Completion date

2011-07-31

Last updated

2014-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy, Heart Failure

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.

Interventions

OTHERSequential 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.

OTHERSimultaneous 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026