Cardiac Arrhythmia
Conditions
Keywords
electrophysiology, atrial fibrillation, cardiac ablation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEElectrophysiology procedure
Electrophysiology testing and cardiac ablation of arrhythmia
Sponsors
Medicept Inc.
CathVision ApS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is scheduled for catheter ablation or diagnostic electrophysiology procedure. * At least 18 years of age. * Able and willing to provide informed consent or obtain consent from a legally authorized representative (LAR).
Exclusion criteria
* Patient inability to understand or refusal to sign informed consent. * Patient is a prisoner or under incarceration * Patients who in the opinion of the physician are not candidates for this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Noise Comparison | EP and ablation procedures can take up to six hours | Measure the peak to peak baseline noise in two EP recording systems for both bipolar and unipolar electrograms in μV |
| Freedom From Major Adverse Events, Evaluated at Hospital Discharge | From EP procedure to discharge is usually one day. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Consecutive patients referred for an electrophysiology study or cardiac ablation. | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Single Arm | — |
|---|---|---|
| Age, Continuous | 63.67 Years STANDARD_DEVIATION 7.27 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 27 participants | — |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 17 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 1 / 27 |
Outcome results
Primary
Baseline Noise Comparison
Measure the peak to peak baseline noise in two EP recording systems for both bipolar and unipolar electrograms in μV
Time frame: EP and ablation procedures can take up to six hours
Population: Baseline noise
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Single Arm | Baseline Noise Comparison | ECGenius Bipolar Baseline Noise | 19 μV |
| Single Arm | Baseline Noise Comparison | ECGenius Unipolar Baseline Noise | 46 μV |
| Single Arm | Baseline Noise Comparison | LabSystem Pro Bipolar Baseline Noise | 31 μV |
| Single Arm | Baseline Noise Comparison | LabSystem Pro Unipolar Noise | 463 μV |
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.
Time frame: From EP procedure to discharge is usually one day.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Freedom From Major Adverse Events, Evaluated at Hospital Discharge | 26 Participants |