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.

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.

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
Measure Time Frame
The number of patients in sinus rhythm at 12 months. 12 month
Secondary Outcome
Measure Time Frame
Extension of AERP Day 0, peri-procedural.
Enrollment 12
Condition
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]

Location
Facility: Status: Contact: Tbilisi Heart & Vascular Clinic Tamaz Shaburishvili, MD
Location Countries

Georgia

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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