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| Name | Class |
|---|---|
| iBeat Inc. | UNKNOWN |
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The iBeat Study is a single-center, prospective, unblinded validation of the photoplethysmography (PPG) and tissue oximetry (TO) signal waveforms recorded from a wrist-based sensor devices.
The goal of the proposed research is to validate PPG and TO signal waveforms recorded from a wist-based sensor device, which is worn on one or both arms, during catheter ablation, device interrogation, and defibrillation threshold testing (DFT). It is a non-invasive procedure that will include placing a wrist-based sensor on subjects who consent participate. Data collected from routine clinical care devices used during these procedures (catheter ablations, device interrogations, and DFTs) will confirm data collected from the iBeat wristwatch.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Subjects presenting for catheter ablation for cardiac arrhythmias (e.g. atrial fibrillation, supraventricular tachycardia, or ventricular tachycardia) |
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| Group B | Subjects judged based on the clinical evaluation of high, greater than 75%, atrial pacing or ventricular pacing burden or known pacing dependence with planned device interrogation for: 1) pacemaker (single or dual chamber), 2) implantable cardioverter-defibrillator (single or dual chamber), or 3) cardiac resynchronization therapy with or without defibrillator (single or dual chamber plus left ventricular pacing). |
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| Group C | Subjects for clinically indicated defibrillation threshold testing (DFT) (with a transvenous or subcutaneous implantable cardioverter defibrillator (ICD) lead system) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iBeat wristwatch device | Device | The participant will be asked to wear one iBeat wristwatch device on each arm during the planned procedure. |
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| Measure | Description | Time Frame |
|---|---|---|
| Detect hemodynamic significant (e.g. Ventricular tachycardia, ventircular fibrillatio, supra ventricular tachycardia with fast ventricular rate, etc) arrhythmias using photoplethysmography | Detect hemodynamic significant arrhythmia using changes in photoplethysmography [PPG] as measured using a wrist-watch. | Immediate |
| Detect hemodynamic significant (e.g. Ventricular tachycardia, ventircular fibrillatio, supra ventricular tachycardia with fast ventricular rate, etc) arrhythmias using tissue oxygenation | Detect hemodynamic significant arrhythmia using changes in tissue oxygenation as measured using a wrist-watch. | Immediate |
| Measure | Description | Time Frame |
|---|---|---|
| Detect benign arrhythmia (e.g. sinus tachycardia, atrial flutter, atrial fibrillation supra-ventricular tachycardia) using changes in photoplethysmography | Detect hemodynamic significant arrhythmia by using changes in photoplethysmography signal, as measured using a wrist-watch. | Immediate |
| Detect benign arrhythmia (e.g. sinus tachycardia, atrial flutter, atrial fibrillation supra-ventricular tachycardia) using changes in tissue oxygenation |
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Inclusion Criteria:
3.1 Group A (25 subjects): Subjects presenting for catheter ablation for cardiac arrhythmias (e.g. atrial fibrillation, supraventricular tachycardia, or ventricular tachycardia) 3.2 Group B (25 subjects): Subjects judged based on the clinical evaluation of high, greater than 75%, atrial pacing or ventricular pacing burden or known pacing dependence with planned device interrogation for: 1) pacemaker (single or dual chamber), 2) implantable cardioverter-defibrillator (single or dual chamber), or 3) cardiac resynchronization therapy with or without defibrillator (single or dual chamber plus left ventricular pacing).
3.3 Group C (5 subjects): Subjects for clinically indicated defibrillation threshold testing (DFT) (with a transvenous or subcutaneous ICD lead system)
Exclusion Criteria:
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The study population will consist of adults that present for either catheter ablation, cardiac device interrogation, or defibrillation threshold testing.
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Olgin, MD | University of California, San Francisco | Principal Investigator |
| Robert Avram, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
The patient data will not be shared with other researchers. However, study outcomes will be published in peer-reviewed journals.
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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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Detect hemodynamic significant arrhythmia by using changes in tissue oxygenation signal, as measured using a wrist-watch. |
| Immediate |