Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation
Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation
| Sponsors |
Lead Sponsor: Atrian Medical Ltd. |
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| Source | Atrian Medical Ltd. |
| 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. |
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| Overall Status | Recruiting | ||||
| Start Date | 2022-06-01 | ||||
| Completion Date | 2023-06-30 | ||||
| Primary Completion Date | 2023-06-30 | ||||
| Phase | N/A | ||||
| Study Type | Interventional | ||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 12 |
| Condition | |
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| Intervention |
Intervention Type: Device Intervention Name: Pulsed Field Ablation of epicardial Ganglionated Plexi. Description: Using Pulsed Field Ablation (PFA), delivered via an epicardial catheter, to selectively ablate the ganglionated plexi (GP) on the epicardial surface of the heart. |
| 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 Gender: All Minimum Age: 18 Years Maximum Age: 70 Years Healthy Volunteers: No |
| Overall Contact |
Last Name: Barry O'Brien Phone: +353872934292 Email: [email protected] |
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| Location |
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| Location Countries |
Georgia |
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| Verification Date |
2022-06-01 |
| Responsible Party |
Type: Sponsor |
| Has Expanded Access | No |
| Condition Browse | |
| Acronym | Neural-AF-2 |
| Patient Data | No |
| Study Design Info |
Allocation: N/A Intervention Model: Single Group Assignment Primary Purpose: Treatment Masking: None (Open Label) |
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