Pilot Study of the CoVa™ Monitoring of Patients With Congestive Heart Failure (CoVa)
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ClinicalTrials.gov Identifier: NCT02368184 |
Recruitment Status
:
Withdrawn
(Sponsor decided not to go forward with study. No subjects were enrolled.)
First Posted
: February 20, 2015
Last Update Posted
: May 25, 2016
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Condition or disease |
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Congestive Heart Failure |
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Pilot Study of the CoVa™ Monitoring of Patients With Congestive Heart Failure |
Study Start Date : | February 2015 |
Actual Primary Completion Date : | May 2016 |
Actual Study Completion Date : | May 2016 |

- Track physiologic parameters among patients with ADHF and explore predictive algorithms to allow for early ID of patients at risk of ADHF. [ Time Frame: 65 days ]
- To track on a daily basis important physiologic parameters among patients with a primary diagnosis of acute decompensated heart failure (ADHF) beginning at the time of their hospitalization and then continued for up to 60 days after discharge, in order to better understand their inter- and intra- individual variability and compare this to standard monitoring including daily weights.
- To explore the development of predictive algorithms to allow for the early identification of patients at risk of acute decompensation and/or HF hospitalization.
- Compare transthoracic impedance in individuals who already have a Medtronic implanted device with OptiVol technology. [ Time Frame: 65 days ]Compare transthoracic impedance measured noninvasively with the CoVa and invasively in individuals who already have a Medtronic implanted device with OptiVol technology.

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Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Adults over age 18
- Have wireless internet access within their homes.
-
Acute hospitalization with a primary diagnosis of acute decompensated heart failure (ADHF) diagnosed on the basis of all of the following:
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Symptoms:
- Onset or worsening of dyspnea within the past 2 weeks
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Physical exam (at least 1 present):
- Rales/ Crackles on auscultation
- Elevated JVP > 8 cmH2O
- Weight gain
- LE edema
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Diagnostic imaging/ labs (at least 1 present):
- Evidence of pulmonary congestion or edema on chest X-ray/ chest CT
- Elevated NT-pro-BNP (age-adjusted) (>1000)
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- Patients of particular interest will be those who already have a Medtronic Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy device with the OptiVol feature that tracks transthoracic impedance.
Exclusion Criteria:
- Allergy to ECG electrodes
- Psychological or social situation that would make the study difficult for the patient
- Inability to consent
- Pregnant women
- Pneumonia - currently, or within the past 30 days
- Non-cardiogenic pulmonary edema (e.g. ARDS)
- Interstitial lung disease
- End-stage renal disease and on hemodialysis
- For any reason unable to wear or place the CoVa™ device, e.g. pectus excavatum, fragile skin, severe arthritis.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02368184
United States, California | |
Scripps Health | |
San Diego, California, United States, 92037 |
Principal Investigator: | Steven Steinhuble, MD | Scripps Translational Science Institute |
Responsible Party: | Scripps Translational Science Institute |
ClinicalTrials.gov Identifier: | NCT02368184 History of Changes |
Other Study ID Numbers: |
15-6537 |
First Posted: | February 20, 2015 Key Record Dates |
Last Update Posted: | May 25, 2016 |
Last Verified: | May 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Scripps Translational Science Institute:
noninvasive physiologic monitoring acute decompensated heart failure (ADHF) |
Additional relevant MeSH terms:
Heart Failure Heart Diseases Cardiovascular Diseases |