N/A
N=24
Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for AF
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT04775264 ↗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
| Outcome | Result | p-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
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.