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Sponsor decided not to go forward with study. No subjects were enrolled.
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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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The purpose of this study is to obtain observational data allowing for the preliminary assessment of the utility of a noninvasive physiologic monitor for monitoring of patients with congestive heart failure.
The study proposes to utilize the CoVaâ„¢ Monitoring System, a novel body-worn sensor that remotely monitors thoracic fluid, heart rate, heart rate variability, respiration rate, skin temperature, posture, and, using transmitted waveforms, stroke volume and cardiac output to evaluate the system's monitoring capabilities in individuals recently hospitalized for congestive heart failure. The data acquired through this study will play a critical roll in developing future interventional studies that will allow patients with HF to potentially receive better and more timely treatment in the home setting, decreasing hospitalizations and improving quality of life.
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| Measure | Description | Time Frame |
|---|---|---|
| Track physiologic parameters among patients with ADHF and explore predictive algorithms to allow for early ID of patients at risk of ADHF. |
| 65 days |
| Measure | Description | Time Frame |
|---|---|---|
| Compare transthoracic impedance in individuals who already have a Medtronic implanted device with OptiVol technology. | Compare transthoracic impedance measured noninvasively with the CoVa and invasively in individuals who already have a Medtronic implanted device with OptiVol technology. | 65 days |
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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:
Symptoms:
Physical exam (at least 1 present):
Diagnostic imaging/ labs (at least 1 present):
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:
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The study population will be made up of adult men and women admitted to the hospital with a primary clinical diagnosis of acute decompensated heart failure. A convenience sample of 25 individuals meeting the following Inclusion criteria and have no Exclusion criteria will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Steven Steinhuble, MD | Scripps Translational Science Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Health | San Diego | California | 92037 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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