Clinical trial NCT04775264: Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for AF
Official title: Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Atrian Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Device-related Primary Safety Adverse Events
timeFrame: 30 days
measure: Number of Participants in Which Pulsed Electric Field Was Successfully Delivered to All Target Sites on the Epicardial Surface of the Heart.
timeFrame: Intraprocedural - during the ablation procedure. Within 1 hour of sternotomy.
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Tbilisi
country: Georgia
facility: Tbilisi Heart & Vascular Clinic
Study officials:
affiliation: AtriAN Medical
name: Barry O'Brien, PhD
role: STUDY_CHAIR
References: