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

NCT ID: NCT05426759

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-06-30

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GP Ablation

Single arm study with GP ablations performed during open-chest surgery

Group Type: EXPERIMENTAL

Pulsed Field Ablation of epicardial Ganglionated Plexi.

Intervention Type: DEVICE

Using Pulsed Field Ablation (PFA), delivered via an epicardial catheter, to selectively ablate the ganglionated plexi (GP) on the epicardial surface of the heart.

Interventions

Pulsed Field Ablation of epicardial Ganglionated Plexi.

Using Pulsed Field Ablation (PFA), delivered via an epicardial catheter, to selectively ablate the ganglionated plexi (GP) on the epicardial surface of the heart.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atrian Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tbilisi Heart & Vascular Clinic

Tbilisi, , Georgia

Countries

Georgia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CIP-002

Identifier Type: -

Identifier Source: org_study_id