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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Right atrial ablation group |
| ||
| Bi-atrial ablation group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Burden of syncopal episodes | Comparison betwen the mounthly burden of syncopal episodes before and after ablation; | through study completion, an average of 1 year |
| heart rate (HR) and heart rate variability (HRV) |
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Inclusion Criteria:
Exclusion Criteria:
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Established asystolic reflex syncope
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michele Brignole, Cardiologist | Contact | +393204391422 | mbrignole@outlook.it | |
| Luca Grappiolo | Contact | +3902619111 | 2894 | luca.grappiolo@auxologico.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto Auxologico Italiano | Milan | 20149 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38036236 | Result | 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. | |
| 40412604 | 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. |
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After 6 months from the publication of the study upon reasonable request
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| ID | Term |
|---|---|
| D019462 | Syncope, Vasovagal |
| D013575 | Syncope |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 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. |
|
Pattern of heart rate (HR) and heart rate variability (HRV) detected by ILR before andafter ablation.
| through study completion, an average of 1 year |
| Time to first asystolic and syncope recurrence | Tme to first asystolic pause >3 sec e and to first syncope recurrence | through study completion, an average of 1 year |
| 39082698 | 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. |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |