Trial Outcomes & Findings for Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for AF (NCT NCT04775264)

NCT ID: NCT04775264

Last Updated: 2024-02-09

Results Overview

Primary Safety Adverse Events include: 1. Atrial perforation or excessive bleeding (excessive bleeding is defined as bleeding which requires any blood transfusion). 2. Pericarditis 3. Pericardial effusion 4. Cardiac tamponade (if either surgical or percutaneous drainage is required). 5. Constrictive pericarditis, requiring re-operation. 6. Newly developed sinus node dysfunction. 7. Newly developed first, second or third degree atrioventricular (AV) block 8. Vasovagal reactions during hospital stay 9. Ventricular fibrillation

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2024-02-09

Participant Flow

Participant milestones

Measure	Pulsed Electric Field Ablation of Ganglionated Plexi Pulsed Electric Field Ablation: Catheter ablation of ganglionated plexi structures on the epicardial surface of the heart during cardiothoracic surgery.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Pulsed Electric Field Ablation of Ganglionated Plexi n=24 Participants Pulsed Electric Field Ablation: Catheter ablation of ganglionated plexi structures on the epicardial surface of the heart during cardiothoracic surgery.
Age, Continuous	61.1 years STANDARD_DEVIATION 7.7 • n=24 Participants
Sex: Female, Male Female	7 Participants n=24 Participants
Sex: Female, Male Male	17 Participants n=24 Participants
Region of Enrollment Czechia	8 participants n=24 Participants
Region of Enrollment Georgia	16 participants n=24 Participants
Body Mass Index	29.4 Kg/m˄2 STANDARD_DEVIATION 4.4 • n=24 Participants
Left Atrial Diameter	3.7 cm STANDARD_DEVIATION 0.4 • n=24 Participants
Left Ventricular Ejection Fraction	49.7 % (of total left ventricle volume) STANDARD_DEVIATION 7.4 • n=24 Participants
Paroxysmal AF History	3 Participants n=24 Participants
Coronary Artery Disease	22 Participants n=24 Participants
Prior Myocardial Infarction	2 Participants n=24 Participants
Hypertension	23 Participants n=24 Participants
Diabetes	9 Participants n=24 Participants
Stroke or TIA (Transient Ischemic Attack)	0 Participants n=24 Participants
Beta Blockers	19 Participants n=24 Participants
Class I or III anti-arrhythmic	0 Participants n=24 Participants

PRIMARY outcome

Timeframe: 30 days

Primary Safety Adverse Events include:

1. Atrial perforation or excessive bleeding (excessive bleeding is defined as bleeding which requires any blood transfusion).

2. Pericarditis

3. Pericardial effusion

4. Cardiac tamponade (if either surgical or percutaneous drainage is required).

5. Constrictive pericarditis, requiring re-operation.

6. Newly developed sinus node dysfunction.

7. Newly developed first, second or third degree atrioventricular (AV) block

8. Vasovagal reactions during hospital stay

9. Ventricular fibrillation

Outcome measures

Measure	Pulsed Electric Field Ablation of Ganglionated Plexi n=24 Participants Pulsed Electric Field Ablation: Catheter ablation of ganglionated plexi structures on the epicardial surface of the heart during cardiothoracic surgery.
Number of Participants With Device-related Primary Safety Adverse Events	0 Participants

PRIMARY outcome

Timeframe: Intraprocedural - during the ablation procedure. Within 1 hour of sternotomy.

Confirmation of catheter access and delivery of pulsed electric field energy to each of the targeted ablation sites on the epicardial surface of the heart.

Outcome measures

Measure	Pulsed Electric Field Ablation of Ganglionated Plexi n=24 Participants Pulsed Electric Field Ablation: Catheter ablation of ganglionated plexi structures on the epicardial surface of the heart during cardiothoracic surgery.
Number of Participants in Which Pulsed Electric Field Was Successfully Delivered to All Target Sites on the Epicardial Surface of the Heart.	24 Participants

Adverse Events

Pulsed Electric Field Ablation of Ganglionated Plexi

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pulsed Electric Field Ablation of Ganglionated Plexi n=24 participants at risk Pulsed Electric Field Ablation: Catheter ablation of ganglionated plexi structures on the epicardial surface of the heart during cardiothoracic surgery.
Cardiac disorders Post-operative Atrial Fibrillation	8.3% 2/24 • Number of events 2 • 30 days
Vascular disorders Pulmonary Embolism	4.2% 1/24 • Number of events 1 • 30 days

Other adverse events

Measure	Pulsed Electric Field Ablation of Ganglionated Plexi n=24 participants at risk Pulsed Electric Field Ablation: Catheter ablation of ganglionated plexi structures on the epicardial surface of the heart during cardiothoracic surgery.
Cardiac disorders Intra-procedural Hypotension and Atrial Fibrillation	4.2% 1/24 • Number of events 1 • 30 days
Cardiac disorders Intra-procedural Atrial Fibrillation	4.2% 1/24 • Number of events 1 • 30 days
Cardiac disorders Atrial Fibrillation	4.2% 1/24 • Number of events 1 • 30 days
Cardiac disorders Post-operative Atrial Fibrillation	16.7% 4/24 • Number of events 5 • 30 days

Additional Information

Barry O'Brien

AtriAN Medical Ltd

Phone: +353872934292

Email: barry.obrien@atrianmedical.com

Results disclosure agreements

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