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The LINQ QT Study is a prospective, non-randomized, multi-center, observational, post-market clinical study investigating QT interval changes due to antiarrhythmic drug loading.
The purpose of this study is to determine if QT interval changes are detected during and after antiarrhythmic drug loading by the designed QT detection algorithm from LINQ ECG.
The QT intervals during the anti arrhythmic loading hospitalization period will be compared for all patients to analyze QT changes that may be caused due to antiarrhythmic drugs.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LINQ/LINQ II | Device | Algorithm developed and validated to continuously measure QT intervals for every beat using LINQ/LINQ II ECG. This study is aimed at determining if QT interval changes can be detected during antiarrhythmic drug loading by the designed QT detection algorithm from LINQ/LINQ II ECG. |
| Measure | Description | Time Frame |
|---|---|---|
| QT Intervals During Antiarrhythmic Loading Hospitalization | The QT intervals during antiarrhythmic loading will be compared for all patients with available LINQ ECG from the baseline anti arrhythmic loading hospitalization to analyze QT changes that may be caused due to antiarrhythmic drugs. | Assessed in the 2-hr period after each of the first four doses, difference between the maximum and minimum QTc interval reported |
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Inclusion Criteria:
Exclusion Criteria:
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The subject population for the LINQ QT Study is a patient implanted with LINQ/LINQII or scheduled for a LINQ/LINQII and who are scheduled to receive an antiarrhythmic drug loading, may undergo this study.
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| Name | Affiliation | Role |
|---|---|---|
| Antony Chu, MD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Hospital | Jacksonville | Florida | 32207 | United States | ||
| OhioHealth Research and Innovation Institute (OHRI) |
There is no plan to share individual patient data with other researchers who were not investigators in the clinical study.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | Anti-arrhythmic loading event |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects with Completed Baseline and AA-loading Event
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With Completed Baseline Anti Arrhythmic Loading Hospitalization | Characteristics of Subjects with completed Baseline Anti Arrhythmic Loading Hospitalization |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | QT Intervals During Antiarrhythmic Loading Hospitalization | The QT intervals during antiarrhythmic loading will be compared for all patients with available LINQ ECG from the baseline anti arrhythmic loading hospitalization to analyze QT changes that may be caused due to antiarrhythmic drugs. | 8 patients (avg. age 68±6.5 years, 63% males) with available LINQ ECG data during the anti arrhythmic loading hospitalization. | Posted | Mean | Standard Deviation | milliseconds | Assessed in the 2-hr period after each of the first four doses, difference between the maximum and minimum QTc interval reported |
|
90 days
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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 | All Subjects | All Subjects Enrolled | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalemia | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
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Continuous telemetered ICM ECG data available during the index antiarrhythmic loading hospitalization period was collected and available in 8 out of 21 patients enrolled (avg. age 68±6.5 years, 63% males) in the QT study and were included in this analysis. 12-lead ECG data was not available for 13 enrolled subjects due to Holter compatibility and technical issues.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antony Chu, M.D., FACC, FAHA, FHRS, FACP, Director of Complex Ablation - Arrhythmia Services Section | Division of Cardiology at the Rhode Island and Miriam Hospital, Warren Alpert School of Medicine, Brown University | 401-444-8689 | antony_chu@brown.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: LINQ QT Study Protocol | Sep 21, 2022 | Nov 25, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Columbus |
| Ohio |
| 43214-3467 |
| United States |
| Bay Area Hospital | Coos Bay | Oregon | 97420 | United States |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Medical History | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 21 |
| 2 |
| 21 |
| 0 |
| 21 |
| Adverse Drug Reaction | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
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