Clinical trial NCT05426759: Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation
Official title: Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Atrian Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Number of Patients in Sinus Rhythm at 12 Months.
timeFrame: 12 month
Secondary outcomes:
measure: Extension of AERP
timeFrame: Day 0
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Tbilisi Heart & Vascular Clinic
Study officials:
References: