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The purpose of this observational study is to collect and characterize multiple physiologic data from a broad subset of subjects with acute heart failure (HF)
Changes in physiologic data are expected to correlate with 30-day readmission rates in this population
This is a multi-center, non-randomized feasibility study aimed at obtaining data from systolic and diastolic HF subjects in the hospital, with continued monitoring using an external wearable monitor for up to 4 weeks post-hospital-discharge. Data will be collected during the hospital stay and at in office follow-up visits at 1 week and 1 month post-hospital discharge
The data will help generate hypotheses and aid in determining whether development of a detection algorithm for acute heart failure decompensation is feasible. Due to the feasibility nature of this study there is no minimum required sample size but it is anticipated that the study will enroll up to 100 subjects from seven (7) study sites in the United States and one (1) study site in Australia
The study objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVIVO™ PiiX Patch Monitor System | Heart failure patients monitored continuously for 30 days post-discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVIVO™ PiiX Patch Monitor System | Device | External monitoring for 30 days post-discharge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Health Care Utilizations | Percentage of Participants with health care utilizations. Healthcare utilizations include hospitalizations, urgent care visits and emergency department visits. | 30 days post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight Per Unit Change in Thoracic Impedance | Change in body weight per unit change in thoracic impedance. The regression coefficients between body weight and thoracic impedance. | Discharge to 30 days post discharge |
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Inclusion Criteria:
Exclusion Criteria:
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Heart failure patients who are admitted to the hospital.
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| Name | Affiliation | Role |
|---|---|---|
| READMIT-HF Study Team | Medtronic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Green Hospital | La Jolla | California | 92037 | United States | ||
| Bay Area Cardiology |
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| ID | Title | Description |
|---|---|---|
| FG000 | AVIVO™ PiiX Patch Monitor System | Heart failure patients monitored continuously for 30 days post-discharge. AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrollment
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| ID | Title | Description |
|---|---|---|
| BG000 | AVIVO™ PiiX Patch Monitor System | Heart failure patients monitored continuously for 30 days post-discharge. AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Health Care Utilizations | Percentage of Participants with health care utilizations. Healthcare utilizations include hospitalizations, urgent care visits and emergency department visits. | Posted | Number | 95% Confidence Interval | percentage of participants | 30 days post-discharge |
|
|
From enrollment to 3 months post-discharge
An adverse event (AE) is considered a serious AE if it
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AVIVO™ PiiX Patch Monitor System | Heart failure patients monitored continuously for 30 days post-discharge. AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fribrillation | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure congestive | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Lautenbach | Medtronic, Inc | 7633609163 | amy.a.lautenbach@medtronic.com@medtronic.com |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Tampa |
| Florida |
| 33511-5908 |
| United States |
| United Heart and Cardiovascular | Saint Paul | Minnesota | 55102-2568 | United States |
| Morristown Memorial Hospital | Morristown | New Jersey | 07962 | United States |
| Mohawk Valley Heart Institute | Utica | New York | 13501-5930 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219-2364 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Change in Body Weight Per Unit Change in Thoracic Impedance | Change in body weight per unit change in thoracic impedance. The regression coefficients between body weight and thoracic impedance. | All subjects with changes of body weight and impedance from discharge to 30 days post discharge. | Posted | Mean | 95% Confidence Interval | lbs/Ohm | Discharge to 30 days post discharge |
|
|
|
| 14 |
| 70 |
| 9 |
| 70 |
| Cardiac Failure Acute | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac Failure congrestive | Cardiac disorders | Non-systematic Assessment |
|
| Supraventricular Tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| HyperKalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Mental Status Changes | Psychiatric disorders | Non-systematic Assessment |
|
| Renal Failure Chronic | Renal and urinary disorders | Non-systematic Assessment |
|
| Scrotal Oedema | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Arteriovenous Fistula | Vascular disorders | Non-systematic Assessment |
|
| Application Site Bruise | General disorders | Non-systematic Assessment |
|
| Application Site Rash | General disorders | Non-systematic Assessment |
|
| Blood Thyroid Stimlating Hormone Increased | Investigations | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | Non-systematic Assessment |
|
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