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| Name | Class |
|---|---|
| Medicept Inc. | INDUSTRY |
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The primary objective is to evaluate the safety and technical performance of the CathVision ECGenius® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available systems in patients undergoing assessment and ablation of cardiac arrhythmias.
A prospective, single center, open-label, single arm study to evaluate the safety and technical performance of the CathVision ECGenius® system.
Patients undergoing assessment and ablation of cardiac arrhythmias during an electrophysiology (EP) procedure, and who meet all inclusion criteria will be enrolled in the study and undergo the EP procedure. Intracardiac signals will be passively recorded using the CathVision ECGenius® System in parallel with a commercial EP recording system and later compared and evaluated. The investigational device will not be used for direct clinical care decisions or therapy. The EP procedure will be guided by the study site Standards Of Care.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrophysiology procedure | Device | Electrophysiology testing and cardiac ablation of arrhythmia |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Noise Comparison | Measure the peak to peak baseline noise in two EP recording systems for both bipolar and unipolar electrograms in μV | EP and ablation procedures can take up to six hours |
| Freedom From Major Adverse Events, Evaluated at Hospital Discharge | Freedom from major adverse events, evaluated at hospital discharge Adverse events were categorized as one of: An adverse event (AE) A serious adverse event (SAE) An Adverse device effect (ADE) is an AE related to the use of an investigational medical device. A Serious adverse device effect (SADE) is an ADE that that has resulted in any of the consequences characteristic of an SAE. An unanticipated adverse device effect (UADE) is defined as any serious adverse effect on health, safety, any life-threatening problem, death caused by or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in predicate devices, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. | From EP procedure to discharge is usually one day. |
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Inclusion Criteria:
Exclusion Criteria:
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patients indicated for EP study or cardiac ablation.
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| Name | Affiliation | Role |
|---|---|---|
| Nathaniel C Thompson, MD PhD | The University of Vermont Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of vermont | Burlington | Vermont | 05401 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | Consecutive patients referred for an electrophysiology study or cardiac ablation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Consecutive patients referred for an electrophysiology study or cardiac ablation. |
| 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 | Baseline Noise Comparison | Measure the peak to peak baseline noise in two EP recording systems for both bipolar and unipolar electrograms in μV | Baseline noise | Posted | Median | Inter-Quartile Range | μV | EP and ablation procedures can take up to six hours |
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from hospital admission to discharge, typically one day.
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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 | Consecutive patients referred for an electrophysiology study or cardiac ablation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | Systematic Assessment | pericardial effusion after transeptal puncture requiring pericardial drainage. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | CathVision ApS | +4531324745 | kpf@cathvision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 9, 2021 | Mar 8, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 27, 2023 | Mar 8, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Freedom From Major Adverse Events, Evaluated at Hospital Discharge | Freedom from major adverse events, evaluated at hospital discharge Adverse events were categorized as one of: An adverse event (AE) A serious adverse event (SAE) An Adverse device effect (ADE) is an AE related to the use of an investigational medical device. A Serious adverse device effect (SADE) is an ADE that that has resulted in any of the consequences characteristic of an SAE. An unanticipated adverse device effect (UADE) is defined as any serious adverse effect on health, safety, any life-threatening problem, death caused by or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in predicate devices, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. | Posted | Count of Participants | Participants | From EP procedure to discharge is usually one day. |
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| 27 |
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| 27 |
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