Trial Outcomes & Findings for An Evaluation of the Safety and Performance of the CathVision ECGenius® System. (NCT NCT05301803)

Results Overview

Measure the peak to peak baseline noise in two EP recording systems for both bipolar and unipolar electrograms in μV

Recruitment status

COMPLETED

Target enrollment

27 participants

Primary outcome timeframe

EP and ablation procedures can take up to six hours

Results posted on

2024-09-05

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm Consecutive patients referred for an electrophysiology study or cardiac ablation.
Overall Study STARTED	27
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=27 Participants Consecutive patients referred for an electrophysiology study or cardiac ablation.
Age, Continuous	63.67 Years STANDARD_DEVIATION 7.27 • n=27 Participants
Sex: Female, Male Female	10 Participants n=27 Participants
Sex: Female, Male Male	17 Participants n=27 Participants
Region of Enrollment United States	27 participants n=27 Participants

PRIMARY outcome

Timeframe: EP and ablation procedures can take up to six hours

Population: Baseline noise

Measure the peak to peak baseline noise in two EP recording systems for both bipolar and unipolar electrograms in μV

Outcome measures

Outcome measures
Measure	Single Arm n=25 Participants Consecutive patients referred for an electrophysiology study or cardiac ablation.
Baseline Noise Comparison ECGenius Unipolar Baseline Noise	46 μV Interval 20.0 to 126.0
Baseline Noise Comparison LabSystem Pro Bipolar Baseline Noise	31 μV Interval 22.0 to 38.0
Baseline Noise Comparison LabSystem Pro Unipolar Noise	463 μV Interval 138.0 to 525.0
Baseline Noise Comparison ECGenius Bipolar Baseline Noise	19 μV Interval 11.0 to 29.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm n=27 Participants Consecutive patients referred for an electrophysiology study or cardiac ablation.
Freedom From Major Adverse Events, Evaluated at Hospital Discharge	26 Participants

Adverse Events

Single Arm

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=27 participants at risk Consecutive patients referred for an electrophysiology study or cardiac ablation.
Cardiac disorders Pericardial effusion	3.7% 1/27 • Number of events 1 • from hospital admission to discharge, typically one day.

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Manager

CathVision ApS

Phone: +4531324745

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place