Status:
COMPLETED
Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation
Lead Sponsor:
Atrian Medical Ltd.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05426759
Start Date
June 1 2022
End Date
June 30 2023
Last Update
July 3 2024
Active Locations (1)
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1
Tbilisi Heart & Vascular Clinic
Tbilisi, Georgia