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WithdrawnNCT02026635CONFIRM-HFUpdated Feb 6, 2015

Cardiac Compass With Optivol® to Negate Future Inpatient Re-admissions Through Monitoring in HF Patients (CONFIRM-HF)

An observational study in Heart Failure, sponsored by Thomas Jefferson University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-06.

Sponsored by Thomas Jefferson University · Observational

Why this study was withdrawn
No subjects enrolled
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
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Study summary

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

02

Conditions studied

  • Heart Failure

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Keywords

  • heart failure
  • Optivol® cardiac device
  • Medtronic CareLink
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

Browse Heart Failure studies →

Lead sponsor

Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.

Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

hospital inpatients

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

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.

    Time frame: 90 days from enrollment

Secondary outcomes

  1. Heart Failure Clinical Events

    Track HF re-admissions and other clinical encounters between 30 and 90 days post discharge for HF.

    Time frame: 90 days from enrollment

  2. Assess Patient-Reported Quality of Life

    Assess the association between the use of Cardiac Compass Report and OptiVol® and improved HF patient quality of life at both time points (30 and 90 days post discharge) utilizing the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: 90 days from enrollment

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Study locations

1 site
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02026635
Lead sponsor
Thomas Jefferson University
Collaborators
Medtronic
Responsible party
Sponsor
First posted
Jan 3, 2014
Start date
Sep 2013
Primary completion
Feb 2015
Completion
Feb 2015
Last update
Feb 6, 2015

Study contacts

David J Whellan, MD MHS
principal investigator · Thomas Jefferson University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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