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N/A N=24 Treatment

Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for AF

Atrial Fibrillation

Enrolled (actual)
24
Serious AEs
12.5%
Results posted
Feb 2024
Primary outcome: Primary: Number of Participants With Device-related Primary Safety Adverse Events — 0 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Pulsed Electric Field Ablation (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Atrian Medical Ltd.
Primary completion
Jun 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Device-related Primary Safety Adverse Events
PRIMARY
Number of Participants in Which Pulsed Electric Field Was Successfully Delivered to All Target Sites on the Epicardial Surface of the Heart.
24

Summary

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

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) 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04775264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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