NCT02026635

Brief Summary

A research study to determine if heart failure can be medically managed using data collected from cardiac monitoring devices

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 2013

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withdrawn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

Study Start

First participant enrolled

September 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 6, 2015

Status Verified

February 1, 2015

Enrollment Period

1.4 years

First QC Date

December 16, 2013

Last Update Submit

February 4, 2015

Conditions

Heart Failure

Keywords

heart failureOptivol® cardiac deviceMedtronic CareLink

Outcome Measures

Primary Outcomes (1)

  • Physician Use of Cardiac Compass Reports to Determine HF Treatment Decisions

    Assessment will be completed at time of enrollment and days 3 to 7, 14 to 21, 30 and 90 post discharge.

    90 days from enrollment

Secondary Outcomes (2)

  • Heart Failure Clinical Events

    90 days from enrollment

  • Assess Patient-Reported Quality of Life

    90 days from enrollment

Study Arms (1)

Optivol® Device in CareLink

A single cohort group of heart failure patients with already implanted Optivol® capable devices who are discharged home from the hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hospital inpatients

You may qualify if:

  • At least 18 years of age
  • Admission for worsening of HF
  • Discharged to home
  • Have appropriate cardiac device with OptiVol® implanted for at least 34 days prior to enrollment
  • Enrolled in Carelink® system and able to transmit data
  • Able to participate for at least 3 months

You may not qualify if:

  • Post heart transplant or actively listed
  • End-stage (Stage D) HF, including treatment with chronic ionotropic drugs or left ventricular assist device support
  • Stage IV or V chronic renal dysfunction (GFR \<25 mol/min per 1.73 M2)
  • Severe Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen
  • Severe pulmonary hypertension not due to left-sided HF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • David J Whellan, MD MHS

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2013

First Posted

January 3, 2014

Study Start

September 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 6, 2015

Record last verified: 2015-02

Locations

US(1)