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Neural-AF-2: Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation

Sponsor
Atrian Medical Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05426759
Collaborator
(none)
12
Enrollment
1
Location
12.9
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A prospective single-arm study of ganglionated plexi ablation in cardiothoracic surgery patients with a history of atrial fibrillation.

Condition or Disease Intervention/Treatment Phase
  • Device: Pulsed Field Ablation of epicardial Ganglionated Plexi.
 N/A

Detailed Description

This study assesses the use of electroporation/pulsed field ablation (PFA) to selectively ablate ganglionated plexi in cardiothoracic surgery patients with atrial fibrillation. The PFA treatment will be performed in up to 12 patients with a history of paroxysmal atrial fibrillation. The primary end point will be recurrence of atrial fibrillation out to 1 year follow-ups.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Outcome Measures

Primary Outcome Measures

  1. The number of patients in sinus rhythm at 12 months. [12 month]

    Patients will be monitored with 24 hour Holter at 12 months

Secondary Outcome Measures

  1. Extension of AERP [Day 0, peri-procedural.]

    Assessment of atrial effective refractory period (AERP) immediately after sternotomy and immediately after ablation, before the index cardiothoracic surgery commences.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age is between 18 and 70 years.

  • Scheduled for open-chest cardiothoracic surgery, for coronary artery bypass grafting and/or aortic valve repair/replacement

  • Have a documented medical history of paroxysmal or early-stage persistent atrial fibrillation within the previous 12 months.

  • 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 endocardial or epicardial pulmonary vein isolation (PVI), or any other invasive AF therapy

  • Previous or existing pericarditis

  • Use of amiodarone within the previous 12 months.

  • Long-standing persistent atrial fibrillation

  • Indication for mitral or tricuspid valve surgery

  • 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

  • New York Heart Association (NYHA) Class IV heart failure symptoms

  • Left Ventricular Ejection Fraction (LVEF) < 40%, measured by transthoracic echocardiography (TTE)

  • Left atrial diameter > 5.0 cm, measured by transthoracic echocardiography (TTE)

  • The presence of left atrial thrombus when examined by transesophageal echocardiography (TEE)

  • The presence of atrial fibrillation (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 C-reactive protein (CRP) 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tbilisi Heart & Vascular Clinic Tbilisi Georgia

Sponsors and Collaborators

  • Atrian Medical Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Atrian Medical Ltd.
ClinicalTrials.gov Identifier:
NCT05426759
Other Study ID Numbers:
  • CIP-002
First Posted:
Jun 22, 2022
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Atrial Fibrillation

Study Results

No Results Posted as of Jun 22, 2022