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

This study has been completed.
Sponsor:
Collaborator:
St. Jude Medical
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00737490
First received: May 4, 2008
Last updated: July 31, 2014
Last verified: April 2013
  Purpose

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 Intervention
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Duke University:

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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2005
Study Completion Date: July 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737490

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
St. Jude Medical
Investigators
Principal Investigator: Hranitzky Patrick, MD Duke University
Study Director: Patrick Hranitzky, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00737490     History of Changes
Other Study ID Numbers: Pro00007865, 7314
Study First Received: May 4, 2008
Last Updated: July 31, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014