NCT02169076

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

January 5, 2017

Status Verified

January 1, 2017

Enrollment Period

1.7 years

First QC Date

June 18, 2014

Last Update Submit

January 3, 2017

Conditions

Heart Failure

Keywords

Ventricular Assist Device, Cardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (1)

  • Right ventricular function

    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.

    8 weeks

Secondary Outcomes (1)

  • Functional capacity

    8 weeks

Other Outcomes (1)

  • Quality-of-Life

    8 weeks

Study Arms (2)

CRT-On

ACTIVE COMPARATOR

Cardiac Resynchronization Therapy enabled on ICD/Pacemaker device

Device: Cardiac Resynchronization Therapy

CRT-Off

SHAM COMPARATOR

Cardiac Resynchronization Therapy disabled on ICD/Pacemaker device

Device: Cardiac Resynchronization Therapy

Interventions

Cardiac Resynchronization TherapyDEVICE

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.

CRT-OffCRT-On

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Study Officials

  • Rakesh Gopinathannair, MD, MA, FHRS

    University of Louisville

    PRINCIPAL INVESTIGATOR

  • Martin A Espinosa Ginic, MD

    University of Louisville

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 20, 2014

Study Start

September 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

January 5, 2017

Record last verified: 2017-01

Locations

US(1)