Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for AF

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-17

Study Completion Date

2023-04-27

Brief Summary

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A prospective, single arm, multi-center exploratory study of safety and feasibility in the treatment of patients undergoing cardiothoracic surgery.

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Detailed Description

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To assess the safety and feasibility of electroporation/Pulsed Electric Field (PEF) as a technology to achieve selective GP ablation. This treatment will be performed on 30 patients undergoing cardiothoracic surgery. Primary feasibility endpoint will be demonstration of ability to access and deliver Pulsed Electric Field energy to all of the targeted ablation sites.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pulsed Electric Field Energy Ablation

Ablation of ganglionated plexi (GP) structures on the epicardial surface of the heart delivered as a concomitant procedure during open heart surgery.

Group Type EXPERIMENTAL

Pulsed Electric Field Ablation

Intervention Type PROCEDURE

Catheter ablation of Ganglionated Plexi (GP) structures on the epicardial surface of the heart during cardiothoracic surgery

Interventions

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Pulsed Electric Field Ablation

Catheter ablation of Ganglionated Plexi (GP) structures on the epicardial surface of the heart during cardiothoracic surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age is between 18 and 70 years.
* Scheduled for open-chest cardiothoracic surgery, for coronary artery bypass grafting.
* 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 pulmonary vein isolation (PVI).
* Previous or existing pericarditis.
* Persistent or long-standing persistent atrial fibrillation.
* Indication for surgical ablation or PVI for atrial fibrillation.
* Indication for concomitant surgical valve repair or replacement.
* 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.
* NYHA (New York Heart Association) Class IV heart failure symptoms.
* Left ventricular ejection fraction (LVEF) \< 40%, measured by transthoracic echocardiography (TTE).
* Left atrial (LA) diameter \> 5.0 cm, measured by transthoracic echocardiography (TTE).
* The presence of left atrial thrombus when examined by transoesophageal echocardiography (TEE).
* The presence of 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 CRP (C-Reactive Protein) 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