Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07162740

Implantable Loop Recorder and Cardioneuroblation

The study aims to determine which method of vagal ganglia ablation is most effective in preventing recurrences of reflex asystole syncope. Currently, some centers perform ablation only in the right atrium, others in both atria (biatrial). There are no comparative studies between the two procedures

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Reflex Syncope Autonomic Nervous System Diseases Cardiovascular Diseases Consciousness Disorders Heart Arrest Heart Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Orthostatic Intolerance Pathological Conditions, Signs and Symptoms Primary Dysautonomias Signs and Symptoms Syncope Syncope, Vasovagal Unconsciousness

Age range

18 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Istituto Auxologico Italiano

Milan, 20149, Italy

About this study

Cardioneuroablation (CNA) therapy for reflex asystole syncope is becoming increasingly popular. The best method of CNA is debated, with no studies comparing the syncopal recurrence rates of right atrium ablation versus bi-atrial ablation. Evaluating the clinical efficacy of CNA is challenging due to symptom variability, intermittent presentation, complex pathophysiology, and different treatment options. The difficulty of obtaining precise follow-up data in patients with intermittent symptoms is well known. With ILR, more objective tracking can be achieved.

The aim of the study is to verify the efficacy of CNA on the reduction of the asystole reflex documented by continuous monitoring by ILR in patients undergoing right atrial ablation compared to bi-atrial ablation

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 60 years
  • Clinical diagnosis of reflex syncope as per class I criteria of the ESC guidelines
  • History of recurrent severe syncopes (≥2 in the last year or ≥3 in the last 2 years), significantly affecting the quality of life, nonresponding to lifestyle measures.
  • Documentation by means of prolonged ECG monitoring of an asystolic pause >6 sec or of an asystolic syncope >3 sec and/or an asystolic syncope induced during tilt testing (Vasis 2B form).

Exclusion criteria

  • Intrinsic sinus dysfunction or atrioventricular node disease.
  • Constitutional hypotension and orthostatic intolerance syndromes
  • Overt structural heart disease
  • Alternative diagnoses of syncope
  • Pregnancy or breastfeeding

Treatment and study plan

Right atrial ablation

Procedure

Eligible patients receive the implantation of a LuxDx® ILR and are monitored for one month by means of the Latitude Clarity data management system of the device. The usual practice of the centres is unchanged. According to their usual practice, the centre is assigned to right atrial ablation. The patients receive a right atrial procedure accordingly. As per pragmatic design, cross-over are permitted according to investigator judgment. The ablation methods and techniques are left to investigator's decision. They are reported in the CRF.

Bi-atrial ablation

Procedure

Eligible patients receive the implantation of a LuxDx® ILR and are monitored for one month by means of the Latitude Clarity data management system of the device. The usual practice of the centres is unchanged. According to their usual practice, the centre is assigned to bi-atrial ablation. The patients receive a bi-atrial procedure accordingly. As per pragmatic design, cross-over are permitted according to investigator judgment. The ablation methods and techniques are left to investigator's decision. They are reported in the CRF.

Primary outcomes

  1. Mounthly frequency of asystolic episodes >3 sec

    Time frame: through study completion, an average of 1 year

    Frequency of asystolic episodes >3 sec per month detected through ILR monitoring before and after ablation.

  2. Freedom from ablation-related complications

    Time frame: through study completion, an average of 1 year

    Freedom from ablation-related complications and from pacemaker implantation during the follow-up period;

Secondary outcomes

  1. Burden of syncopal episodes

    Time frame: through study completion, an average of 1 year

    Comparison betwen the mounthly burden of syncopal episodes before and after ablation;

  2. heart rate (HR) and heart rate variability (HRV)

    Time frame: through study completion, an average of 1 year

    Pattern of heart rate (HR) and heart rate variability (HRV) detected by ILR before andafter ablation.

  3. Time to first asystolic and syncope recurrence

    Time frame: through study completion, an average of 1 year

    Tme to first asystolic pause >3 sec e and to first syncope recurrence

Study contacts

Contact information is provided by the study sponsor or research team.

Luca Grappiolo

CONTACT

[email protected]

+3902619111 ext. 2894

Michele Brignole, Cardiologist

CONTACT

[email protected]

+393204391422

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

Comparative Study of Right Atrial Versus Bi-atrial Cardioneuroablation of Asystolic Reflex Syncope Verified by Implantable Loop Recorder

Acronym: ILR-CNA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.