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Impact of Cardiac Resynchronization Therapy on Right Ventricular Function in Left Ventricular Assist Device Patients (CRT-LVAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02169076
Recruitment Status : Withdrawn (IRB Approval withdrawn)
First Posted : June 20, 2014
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
University of Louisville

Tracking Information
First Submitted Date  ICMJE June 18, 2014
First Posted Date  ICMJE June 20, 2014
Last Update Posted Date January 5, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
Right ventricular function [ Time Frame: 8 weeks ]
The primary cardiac performance endpoint is global longitudinal right ventricular (RV) function assessed by myocardial strain analysis using Speckle Tracking Echocardiography (STE). Other traditional echocardiographic RV function indexes will also be evaluated.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
Functional capacity [ Time Frame: 8 weeks ]
Will be assessed by 6-Minute Walk Test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 18, 2014)
Quality-of-Life [ Time Frame: 8 weeks ]
Assessed by standardized self administered Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Impact of Cardiac Resynchronization Therapy on Right Ventricular Function in Left Ventricular Assist Device Patients
Official Title  ICMJE Cardiac Resynchronization Therapy in Patients With Left Ventricular Assist Devices
Brief Summary

Left Ventricular Assist Devices (LVAD) are mechanical heart pumps that are increasingly being implanted in patients with severe heart failure which have failed medical therapy. In patients with LVADs, right ventricular failure, which is not supported by the LVAD pump, is a major problem that affects quality-of-life and survival. Cardiac Resynchronization Therapy (CRT) aims to restore the synchronized contraction of the heart and has proven to be beneficial for improving ejection fraction of both right and left ventricle as well as quality of life in selected heart failure patients. The role of CRT in patients with LVADs is unknown. We hypothesize that CRT can exert a beneficial impact on right ventricular function in LVAD patients and improve their quality-of-life.

The specific questions that this study aims to answer are:

  1. What are the effects of CRT on the function of the non-supported right ventricle in patients with an implanted LVAD?
  2. Can the effects of CRT on cardiac function positively impact quality-of-life and exercise capacity in LVAD recipients?

In this study patients with a previously implanted CRT device, who later receives an LVAD, will be randomly assigned to have the CRT turned off (CRT-off) or on (CRT-on). The patients will be followed for an 8-week period, and then switched over to the opposite CRT status. The total participation in this study will last for 16 ± 1 weeks, and will involve 3 clinic visits of approximately 3 hour duration (initial visit, 8 week visit, and 16 week final visit), plus 2 quick checks of the pacemaker/defibrillator in-between the visits. Heart function will be assessed with comprehensive echocardiographic studies during the CRT "on" and CRT "off" periods. Quality-of-life and exercise capacity will be assessed with a standardized questionnaire and a 6-Minute Walk Test.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE Device: Cardiac Resynchronization Therapy
The cardiac resynchronization therapy of the ICD/Pacemaker device of the patients enrolled in the study will be programed under a standardized protocol and enabled or disabled in a crossover fashion during the study.
Study Arms  ICMJE
  • Active Comparator: CRT-On
    Cardiac Resynchronization Therapy enabled on ICD/Pacemaker device
    Intervention: Device: Cardiac Resynchronization Therapy
  • Sham Comparator: CRT-Off
    Cardiac Resynchronization Therapy disabled on ICD/Pacemaker device
    Intervention: Device: Cardiac Resynchronization Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 3, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2014)
30
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Heart failure patients with previously implanted Bi-Ventricular pacemaker / defibrillator, and continuous flow LVAD (Heart Mate II® or HeartWare®)
  • The LVAD must be implanted between 8 weeks and 18 months prior to enrollment
  • Patients should be at least 3 weeks post discharge from the LVAD implant hospitalization

Exclusion Criteria:

  • Severe decompensated right ventricular failure defined as requiring any of the following:

    • Hospitalization for heart failure within last 30 days
    • Need for inotropic infusion for > 48h within the last 14 days
    • Increase of > 100% diuretic dose within last 14 days
  • Severe aortic regurgitation documented by echocardiography or cardiac catheterization
  • Stage IV or greater kidney disease (GFR < 30 mL/min/1.73 m2)
  • Active infection (not including controlled chronic driveline infection on suppressive antibiotic therapy)
  • Biventricular pacing < 90 % of time due to uncontrolled arrhythmias
  • LVAD malfunction
  • Inability to follow study protocol
  • Non-functional LV lead (i.e. high capture threshold that cannot be corrected with programming changes)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02169076
Other Study ID Numbers  ICMJE 14.0338
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Louisville
Study Sponsor  ICMJE University of Louisville
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rakesh Gopinathannair, MD, MA, FHRS University of Louisville
Principal Investigator: Martin A Espinosa Ginic, MD University of Louisville
PRS Account University of Louisville
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP