Trial Outcomes & Findings for Single Center Pilot Study Using the ECGenius System to Collect Electrogram Data to Test an Ablation Impact Algorithm (NCT NCT05458648)

NCT ID: NCT05458648

Last Updated: 2025-12-16

Results Overview

Data collected during the study will be used to test a signal complexity visualization algorithm. The primary outcome measure was the ability of the system to achieve this in each patient.

• Recruitment status: COMPLETED
• Target enrollment: 37 participants
• Primary outcome timeframe: One day - day of procedure
• Results posted on: 2025-12-16

Participant Flow

1 patient was a screen failure (wrong rhythm) after having signed the informed consent.

Participant milestones

Measure	Persistent AF Arm Patients undergoing cardiac ablation for the treatment of persistent atrial fibrillation Cardiac Ablation for the treatment of persistent Atrial Fibrillation: Patients participating in the study will undergo a cardiac ablation for the treatment of persistent atrial fibrillation.
Overall Study STARTED	36
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Persistent AF Arm Patients undergoing cardiac ablation for the treatment of persistent atrial fibrillation Cardiac Ablation for the treatment of persistent Atrial Fibrillation: Patients participating in the study will undergo a cardiac ablation for the treatment of persistent atrial fibrillation.
Overall Study Physician Decision	1
Overall Study Patient presented in atrial flutter	1

Baseline Characteristics

Single Center Pilot Study Using the ECGenius System to Collect Electrogram Data to Test an Ablation Impact Algorithm

Baseline characteristics by cohort

Measure	Persistent AF Arm n=34 Participants Patients undergoing cardiac ablation for the treatment of persistent atrial fibrillation Cardiac Ablation for the treatment of persistent Atrial Fibrillation: Patients participating in the study will undergo a cardiac ablation for the treatment of persistent atrial fibrillation.
Age, Continuous	67.7 years STANDARD_DEVIATION 11.03 • n=6 Participants
Sex: Female, Male Female	10 Participants n=6 Participants
Sex: Female, Male Male	24 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	1 Participants n=6 Participants
Race (NIH/OMB) White	28 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=6 Participants
Height	175.28 cm STANDARD_DEVIATION 11.64 • n=6 Participants

PRIMARY outcome

Timeframe: One day - day of procedure

Data collected during the study will be used to test a signal complexity visualization algorithm. The primary outcome measure was the ability of the system to achieve this in each patient.

Outcome measures

Measure	Persistent AF Arm n=34 Participants Patients undergoing cardiac ablation for the treatment of persistent atrial fibrillation Cardiac Ablation for the treatment of persistent Atrial Fibrillation: Patients participating in the study will undergo a cardiac ablation for the treatment of persistent atrial fibrillation.
Ability to Collect CS Data	34 Participants

SECONDARY outcome

Timeframe: At the start of the procedure from the insertion of the CS catheter to the first ablation

Population: Baseline AFCL

Data collected during the study will be used to test an AF cycle length algorithm

Outcome measures

Measure	Persistent AF Arm n=34 Participants Patients undergoing cardiac ablation for the treatment of persistent atrial fibrillation Cardiac Ablation for the treatment of persistent Atrial Fibrillation: Patients participating in the study will undergo a cardiac ablation for the treatment of persistent atrial fibrillation.
Measurement of AF Cycle Length	169.64 ms Standard Deviation 24.27

Adverse Events

Persistent AF Arm

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Persistent AF Arm n=34 participants at risk Patients undergoing cardiac ablation for the treatment of persistent atrial fibrillation Cardiac Ablation for the treatment of persistent Atrial Fibrillation: Patients participating in the study will undergo a cardiac ablation for the treatment of persistent atrial fibrillation.
Blood and lymphatic system disorders Hemorrhage	2.9% 1/34 • Number of events 1 • The day of the procedure

Other adverse events

Measure	Persistent AF Arm n=34 participants at risk Patients undergoing cardiac ablation for the treatment of persistent atrial fibrillation Cardiac Ablation for the treatment of persistent Atrial Fibrillation: Patients participating in the study will undergo a cardiac ablation for the treatment of persistent atrial fibrillation.
Cardiac disorders Hypotension	2.9% 1/34 • Number of events 1 • The day of the procedure
Cardiac disorders Atrial Tachycardia	2.9% 1/34 • Number of events 1 • The day of the procedure
Cardiac disorders Pericardial Effusion	2.9% 1/34 • Number of events 1 • The day of the procedure

Additional Information

Clinical Research Manager

CathVision ApS

Phone: 0702097102

Email: kpf@cathvision.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place