Atrial Fibrillation
Conditions
Brief summary
A prospective, single arm, multi-center exploratory study of safety and feasibility in the treatment of patients undergoing cardiothoracic surgery.
Detailed description
To assess the safety and feasibility of electroporation/Pulsed Electric Field (PEF) as a technology to achieve selective GP ablation. This treatment will be performed on 30 patients undergoing cardiothoracic surgery. Primary feasibility endpoint will be demonstration of ability to access and deliver Pulsed Electric Field energy to all of the targeted ablation sites.
Interventions
PROCEDUREPulsed Electric Field Ablation
Catheter ablation of Ganglionated Plexi (GP) structures on the epicardial surface of the heart during cardiothoracic surgery
Sponsors
Atrian Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age is between 18 and 70 years. * Scheduled for open-chest cardiothoracic surgery, for coronary artery bypass grafting. * Legally competent and willing to sign the informed consent. * Life expectancy of at least 2 years.
Exclusion criteria
* • Previous cardiac surgery. * Prior pericardial interventions. * Prior pulmonary vein isolation (PVI). * Previous or existing pericarditis. * Persistent or long-standing persistent atrial fibrillation. * Indication for surgical ablation or PVI for atrial fibrillation. * Indication for concomitant surgical valve repair or replacement. * Indication for concomitant left atrial appendage (LAA) ligation or excision. * History of previous radiation therapy on the thorax. * History of previous thoracotomy. * Prior electrical or mechanical isolation of the Left Atrial Appendage (LAA). * The presence of LAA occlusion devices, coronary stents, prosthetic heart valves, pacemakers or implantable cardioverter defibrillators (ICDs). * Myocardial infarction within the previous 2 months. * NYHA (New York Heart Association) Class IV heart failure symptoms. * Left ventricular ejection fraction (LVEF) \< 40%, measured by transthoracic echocardiography (TTE). * Left atrial (LA) diameter \> 5.0 cm, measured by transthoracic echocardiography (TTE). * The presence of left atrial thrombus when examined by transoesophageal echocardiography (TEE). * The presence of AF attributable to non-cardiovascular causes such as thyroid disease, electrolyte imbalance/dehydration or other reversible causes. * Active infection or sepsis as evidenced by increased white blood cell count, elevated CRP (C-Reactive Protein) or temperature \> 38.5°C. * Known or documented carotid stenosis \> 80% * Stroke or transient ischemic attack within the previous 6 months. * Known or documented epilepsy. * Pregnancy or child-bearing potential without adequate contraception. * Circumstances that prevent follow-ups. * Drug abuse. * Patients cannot be enrolled in another clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Device-related Primary Safety Adverse Events | 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 |
| Number of Participants in Which Pulsed Electric Field Was Successfully Delivered to All Target Sites on the Epicardial Surface of the Heart. | 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. |
Countries
Czechia, Georgia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Pulsed Electric Field Ablation of Ganglionated Plexi | — |
|---|---|---|
| Age, Continuous | 61.1 years STANDARD_DEVIATION 7.7 | — |
| Beta Blockers | 19 Participants | — |
| Body Mass Index | 29.4 Kg/m˄2 STANDARD_DEVIATION 4.4 | — |
| Class I or III anti-arrhythmic | 0 Participants | — |
| Coronary Artery Disease | 22 Participants | — |
| Diabetes | 9 Participants | — |
| Hypertension | 23 Participants | — |
| Left Atrial Diameter | 3.7 cm STANDARD_DEVIATION 0.4 | — |
| Left Ventricular Ejection Fraction | 49.7 % (of total left ventricle volume) STANDARD_DEVIATION 7.4 | — |
| Paroxysmal AF History | 3 Participants | — |
| Prior Myocardial Infarction | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Czechia | 8 participants | — |
| Region of Enrollment Georgia | 16 participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 17 Participants | — |
| Stroke or TIA (Transient Ischemic Attack) | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 5 / 24 |
| serious Total, serious adverse events | 3 / 24 |
Outcome results
Primary
Number of Participants in Which Pulsed Electric Field Was Successfully Delivered to All Target Sites on the Epicardial Surface of the Heart.
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.
Time frame: Intraprocedural - during the ablation procedure. Within 1 hour of sternotomy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pulsed Electric Field Ablation of Ganglionated Plexi | Number of Participants in Which Pulsed Electric Field Was Successfully Delivered to All Target Sites on the Epicardial Surface of the Heart. | 24 Participants |
Primary
Number of Participants With Device-related Primary Safety Adverse Events
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
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pulsed Electric Field Ablation of Ganglionated Plexi | Number of Participants With Device-related Primary Safety Adverse Events | 0 Participants |