Implantable Loop Recorder and Cardioneuroblation

NCT07162740 | Not Yet Recruiting

• 1 other identifier: ILR-CNA
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Reflex Syncope

Keywords

Syncope; reflex syncope; implantable loop recorder; Vagal ganglia ablation; Cardioneuroablation; Asystole

Outcome Measures

Primary Outcomes (2)

• Mounthly frequency of asystolic episodes >3 sec

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

  through study completion, an average of 1 year

• Freedom from ablation-related complications

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

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Burden of syncopal episodes

  through study completion, an average of 1 year

• heart rate (HR) and heart rate variability (HRV)

  through study completion, an average of 1 year

• Time to first asystolic and syncope recurrence

  through study completion, an average of 1 year

Study Arms (2)

Right atrial ablation group

Procedure: Right atrial ablation

Bi-atrial ablation group

Procedure: Bi-atrial ablation

Interventions

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.

Right atrial ablation group

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.

Bi-atrial ablation group

Eligibility Criteria

• Age: 18 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Established asystolic reflex syncope

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

IRCCS Istituto Auxologico Italiano

Milan, 20149, Italy

Location

Related Publications (3)

• Kulakowski P, Baran J, Sikorska A, Krynski T, Niedzwiedz M, Soszynska M, Piotrowski R. Cardioneuroablation for reflex asystolic syncope: Mid-term safety, efficacy, and patient's acceptance. Heart Rhythm. 2024 Mar;21(3):282-291. doi: 10.1016/j.hrthm.2023.11.022. Epub 2023 Nov 29.

  PMID: 38036236 RESULT

• Calo L, Rebecchi M, De Ruvo E, Giamundo D, Sette A, Tomaino M, Hunteruber M, Bottoni N, Iori M, Donateo P, Maggi R, Del Rosso A, Rafanelli M, Russo V, Strano S, Brignole M. Right atrial cardioneuroablation of asystolic reflex syncope. Heart Rhythm. 2025 Oct;22(10):e951-e958. doi: 10.1016/j.hrthm.2025.05.038. Epub 2025 May 22.

  PMID: 40412604 RESULT

• Aksu T, Brignole M, Calo L, Debruyne P, Di Biase L, Deharo JC, Fanciulli A, Fedorowski A, Kulakowski P, Morillo C, Moya A, Piotrowski R, Stec S, Sutton R, van Dijk JG, Wichterle D, Tse HF, Yao Y, Sheldon RS, Vaseghi M, Pachon JC, Scanavacca M, Meyer C, Amin R, Gupta D, Magnano M, Malik V, Schauerte P, Shen WK, Acosta JCZ. Cardioneuroablation for the treatment of reflex syncope and functional bradyarrhythmias: A Scientific Statement of the European Heart Rhythm Association (EHRA) of the ESC, the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS) and the Latin American Heart Rhythm Society (LAHRS). Europace. 2024 Aug 3;26(8):euae206. doi: 10.1093/europace/euae206.

  PMID: 39082698 RESULT

MeSH Terms

Conditions

Syncope, Vasovagal; Syncope; Heart Arrest

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Michele Brignole, Cardiologist

CONTACT

+393204391422; mbrignole@outlook.it

Luca Grappiolo

CONTACT

+3902619111; luca.grappiolo@auxologico.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: September 9, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)