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The purpose of the ReLINQuish study is to characterize the relationship between subcutaneous impedance and hemodynamic measurements in patients with heart failure. Additionally, the relationship between changes in subcutaneous impedance and other physiologic parameters during acute decompensated HF events will be characterized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm Study | Experimental | Invesigational RAMware will be downloaded onto the LINQ device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational LINQ™ HF RAMware | Device | The Reveal LINQ™ device and the 2090 programmer are market-released, but once the investigational LINQ™ HF RAMware is downloaded into the devices, they are considered investigational. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Reveal LINQ™ Subcutaneous Impedance (Units of Ohms) With Pulmonary Artery Pressure (Units of mmHg) From a Swan-Ganz Catheter During Right Heart Catheterization Procedures in Patients With Heart Failure. | The primary objective was to characterize the relationship between changes in Reveal LINQ™ subcutaneous impedance and right heart hemodynamic measurements, resulting from: 1) short-term drug and/or exercise challenges during right heart catheterization procedures or 2) long-term daily trends of physiologic data, in patients with heart failure. | 18 months |
| Comparison of Reveal LINQ™ Subcutaneous Impedance (Units of Ohms) With Right Atrial Pressure (Units of mmHg) From a Swan-Ganz Catheter During Right Heart Catheterization Procedures in Patients With Heart Failure. | The primary objective was to characterize the relationship between changes in Reveal LINQ™ subcutaneous impedance and right heart hemodynamic measurements, resulting from: 1) short-term drug and/or exercise challenges during right heart catheterization procedures or 2) long-term daily trends of physiologic data, in patients with heart failure. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of the Changes in Reveal LINQ™ Subcutaneous Impedance (Units of Ohms) Prior to Any Acute Decompensated Heart Failure Events. | The primary objective was to characterize the relationship between changes in Reveal LINQ™ subcutaneous impedance and right heart hemodynamic measurements, resulting from: 1) short-term drug and/or exercise challenges during right heart catheterization procedures or 2) long-term daily trends of physiologic data, in patients with heart failure. |
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Inclusion Criteria:
Patients meeting at least 1 of 3 criteria will be included in the study:
Patient is 18 years of age or older
Patient (or patient's legally authorized representative) is willing and able to provide written informed consent
Patient is willing and able to comply with the protocol, including follow-up visits and Carelink transmissions.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University | Columbus | Ohio | 43210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Study | Observational data collection study |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Study | Single Arm Observational study. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Comparison of Reveal LINQ™ Subcutaneous Impedance (Units of Ohms) With Pulmonary Artery Pressure (Units of mmHg) From a Swan-Ganz Catheter During Right Heart Catheterization Procedures in Patients With Heart Failure. | The primary objective was to characterize the relationship between changes in Reveal LINQ™ subcutaneous impedance and right heart hemodynamic measurements, resulting from: 1) short-term drug and/or exercise challenges during right heart catheterization procedures or 2) long-term daily trends of physiologic data, in patients with heart failure. | Posted | Count of Participants | Participants | 18 months |
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Adverse event data was collected up to 18 months from enrollment.
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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 | Single Arm | Observation Arm | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Cardiac disorders | Systematic Assessment | There was one hospitalization which was deemed a serious adverse event on day 285 after insertion procedure which could not be ruled out as related to device or insertion procedure. |
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No right heart catheterization was performed during the study, hence the primary outcome could not be summarized. The LINQ device data was not available prior to the acute decompensated heart failure events, hence the secondary outcome could not be summarized.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Wood | Medtronic | 8006338766 | nicole.wood@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 17, 2017 | Nov 2, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 18 months |
| Characterization of the Changes in Reveal LINQ™ Activity (Units of Hours Per Day) Prior to Any Acute Decompensated Heart Failure Events. | A heart failure event is defined as any cardiovascular-related (including hypervolemia) Health Care Utilizations (HCUs) for any one of the following events.
| 18 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| History of Coronary Artery Disease | Count of Participants | Participants |
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| History of Hypertension | Count of Participants | Participants |
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| History of Atrial Fibrillation | Count of Participants | Participants |
|
| Left Ventricular Ejection Fraction | Mean | Standard Deviation | % |
|
| NYHA class | NYHA Class I-IV with Class I early stage heart failure, and Class IV end stage heart failure. | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Comparison of Reveal LINQ™ Subcutaneous Impedance (Units of Ohms) With Right Atrial Pressure (Units of mmHg) From a Swan-Ganz Catheter During Right Heart Catheterization Procedures in Patients With Heart Failure. | The primary objective was to characterize the relationship between changes in Reveal LINQ™ subcutaneous impedance and right heart hemodynamic measurements, resulting from: 1) short-term drug and/or exercise challenges during right heart catheterization procedures or 2) long-term daily trends of physiologic data, in patients with heart failure. | Posted | Count of Participants | Participants | 18 months |
|
|
|
| Secondary | Characterization of the Changes in Reveal LINQ™ Subcutaneous Impedance (Units of Ohms) Prior to Any Acute Decompensated Heart Failure Events. | The primary objective was to characterize the relationship between changes in Reveal LINQ™ subcutaneous impedance and right heart hemodynamic measurements, resulting from: 1) short-term drug and/or exercise challenges during right heart catheterization procedures or 2) long-term daily trends of physiologic data, in patients with heart failure. | Posted | Count of Participants | Participants | 18 months |
|
|
|
| Secondary | Characterization of the Changes in Reveal LINQ™ Activity (Units of Hours Per Day) Prior to Any Acute Decompensated Heart Failure Events. | A heart failure event is defined as any cardiovascular-related (including hypervolemia) Health Care Utilizations (HCUs) for any one of the following events.
| Posted | Count of Participants | Participants | 18 months |
|
|
|
| 12 |
| 4 |
| 12 |
| 0 |
| 12 |
|
| Death | Cardiac disorders | Systematic Assessment |
|
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