Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 12

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GP Ablation	Pulsed Field Ablation of epicardial Ganglionated Plexi.	Single arm study with GP ablations performed during open-chest surgery

Primary Outcome Measures

Name	Time	Method
The Number of Patients in Sinus Rhythm at 12 Months.	12 month	Patients will be monitored with 24 hour Holter at 12 months

Secondary Outcome Measures

Name	Time	Method
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.