Atrial Fibrillation
Conditions
Brief summary
A prospective single-arm study of ganglionated plexi ablation in cardiothoracic surgery patients with a history of atrial fibrillation.
Detailed description
This study assesses the use of electroporation/pulsed field ablation (PFA) to selectively ablate ganglionated plexi in cardiothoracic surgery patients with atrial fibrillation. The PFA treatment will be performed in up to 12 patients with a history of paroxysmal atrial fibrillation. The primary end point will be recurrence of atrial fibrillation out to 1 year follow-ups.
Interventions
DEVICEPulsed Field Ablation of epicardial Ganglionated Plexi.
Using Pulsed Field Ablation (PFA), delivered via an epicardial catheter, to selectively ablate the ganglionated plexi (GP) on the epicardial surface of the heart.
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 and/or aortic valve repair/replacement * Have a documented medical history of paroxysmal or early-stage persistent atrial fibrillation within the previous 12 months. * 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 endocardial or epicardial pulmonary vein isolation (PVI), or any other invasive AF therapy * Previous or existing pericarditis * Use of amiodarone within the previous 12 months. * Long-standing persistent atrial fibrillation * Indication for mitral or tricuspid valve surgery * 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 * New York Heart Association (NYHA) Class IV heart failure symptoms * Left Ventricular Ejection Fraction (LVEF) \< 40%, measured by transthoracic echocardiography (TTE) * Left atrial diameter \> 5.0 cm, measured by transthoracic echocardiography (TTE) * The presence of left atrial thrombus when examined by transesophageal echocardiography (TEE) * The presence of atrial fibrillation (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 C-reactive protein (CRP) 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 |
|---|---|---|
| The Number of Patients in Sinus Rhythm at 12 Months. | 12 month | Patients will be monitored with 24 hour Holter at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extension of AERP | Day 0 | The acute increase in atrial effective refractory period (AERP) i.e. by comparing AERP values from immediately before and immediately after ablation. |
Countries
Georgia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Ganglionated Plexi Ablation | — |
|---|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 5.1 | — |
| Anti-Arrhythmic Drugs | 0 Participants | — |
| Beta Blockers | 12 Participants | — |
| Diabetes | 0 Participants | — |
| Hypertension | 12 Participants | — |
| Left Atrial Diameter | 3.6 cm STANDARD_DEVIATION 0.6 | — |
| Left Ventricular Ejection Fraction | 48.4 % (of total left ventricle volume) STANDARD_DEVIATION 4.4 | — |
| Myocardial Infarction | 3 Participants | — |
| Paroxysmal Atrial Fibrillation | 12 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
| Stroke or Transient Ischemic Attack | 0 Participants | — |
| Valve Disease | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 1 / 12 |
Outcome results
Primary
The Number of Patients in Sinus Rhythm at 12 Months.
Patients will be monitored with 24 hour Holter at 12 months
Time frame: 12 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ganglionated Plexi Ablation | The Number of Patients in Sinus Rhythm at 12 Months. | 12 Participants |
Secondary
Extension of AERP
The acute increase in atrial effective refractory period (AERP) i.e. by comparing AERP values from immediately before and immediately after ablation.
Time frame: Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ganglionated Plexi Ablation | Extension of AERP | 12 ms | Standard Deviation 41 |