Trial Outcomes & Findings for Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation (NCT NCT05426759)

Last Updated: 2024-07-03

Results Overview

Patients will be monitored with 24 hour Holter at 12 months

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

12 month

Results posted on

2024-07-03

Participant milestones
Measure	Ganglionated Plexi Ablation Single arm study with Ganglionated Plexi (GP) ablations performed during open-chest cardiothoracic surgery. Ablation is performed using pulsed electric fields, delivered via an epicardial catheter, to selectively ablate the GPs on the epicardial surface of the heart.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Ganglionated Plexi Ablation n=12 Participants Single arm study with Ganglionated Plexi (GP) ablations performed during open-chest cardiothoracic surgery. Ablation is performed using pulsed electric fields, delivered via an epicardial catheter, to selectively ablate the GPs on the epicardial surface of the heart.
Age, Continuous	63.6 years STANDARD_DEVIATION 5.1 • n=12 Participants
Sex: Female, Male Female	2 Participants n=12 Participants
Sex: Female, Male Male	10 Participants n=12 Participants
Left Atrial Diameter	3.6 cm STANDARD_DEVIATION 0.6 • n=12 Participants
Left Ventricular Ejection Fraction	48.4 % (of total left ventricle volume) STANDARD_DEVIATION 4.4 • n=12 Participants
Hypertension	12 Participants n=12 Participants
Diabetes	0 Participants n=12 Participants
Stroke or Transient Ischemic Attack	0 Participants n=12 Participants
Myocardial Infarction	3 Participants n=12 Participants
Paroxysmal Atrial Fibrillation	12 Participants n=12 Participants
Valve Disease	2 Participants n=12 Participants
Beta Blockers	12 Participants n=12 Participants
Anti-Arrhythmic Drugs	0 Participants n=12 Participants

Timeframe: 12 month

Patients will be monitored with 24 hour Holter at 12 months

Outcome measures
Measure	Ganglionated Plexi Ablation n=12 Participants Single arm study with Ganglionated Plexi (GP) ablations performed during open-chest cardiothoracic surgery. Ablation is performed using pulsed electric fields, delivered via an epicardial catheter, to selectively ablate the GPs on the epicardial surface of the heart.
The Number of Patients in Sinus Rhythm at 12 Months.	12 Participants

Timeframe: Day 0

The acute increase in atrial effective refractory period (AERP) i.e. by comparing AERP values from immediately before and immediately after ablation.

Outcome measures
Measure	Ganglionated Plexi Ablation n=10 Participants Single arm study with Ganglionated Plexi (GP) ablations performed during open-chest cardiothoracic surgery. Ablation is performed using pulsed electric fields, delivered via an epicardial catheter, to selectively ablate the GPs on the epicardial surface of the heart.
Extension of AERP	12 ms Standard Deviation 41

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Ganglionated Plexi Ablation n=12 participants at risk Single arm study with Ganglionated Plexi (GP) ablations performed during open-chest cardiothoracic surgery. Ablation is performed using pulsed electric fields, delivered via an epicardial catheter, to selectively ablate the GPs on the epicardial surface of the heart.
Cardiac disorders Atrial bleed	8.3% 1/12 • 1 year

Adverse event data not reported

AtriAN Medical Ltd

Phone: +353872934292