Status:
COMPLETED
Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for AF
Lead Sponsor:
Atrian Medical Ltd.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-70 years
Phase:
NA
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 cardiot...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
May 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04775264
Start Date
May 17 2021
End Date
April 27 2023
Last Update
February 9 2024
Active Locations (2)
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1
Na Homolce Hospital
Prague, Czechia
2
Tbilisi Heart & Vascular Clinic
Tbilisi, Georgia