POLish Registry of CArdioneuroablation and CArdioneuromodulation

RecruitingOBSERVATIONAL
Enrollment

1,000

Participants

Timeline

Start Date

November 21, 2024

Primary Completion Date

December 31, 2030

Study Completion Date

December 31, 2031

Conditions
Vasovagal Syndrome VVSCardioinhibitory Carotid Sinus Syndrome CSSSymptomatic Sinus Bradycardia SB or Atrioventricular Block AVPostural Orthostatic Tachycardia Syndrome POTSOrthostatic HypotensionInappropriate Sinus Tachycardia Syndrome ISTVasospastic AnginaMicrovascular AnginaVentricular ArrythmiaRaynaud PhenomenaAutonomic DysfunctionAutonomic Diseases
Interventions
PROCEDURE

cardioneuroablation

Cardioneuroablation and related autonomic interventions aim to modulate parasympathetic and/or sympathetic inputs to the heart in order to treat functional bradycardia, inappropriate sinus tachycardia, vasovagal syncope, and other reflex arrhythmias. Techniques include catheter-based ablation of ganglionated plexi, thoracoscopic sinus node-sparing ablation, cardiac sympathetic denervation, and percutaneous stellate ganglion blockade. These procedures are tailored to each patient's autonomic profile and diagnosis.

PROCEDURE

SN sparing hybrid ablation

Sinus node-sparing hybrid ablation is a minimally invasive surgical procedure that modulates autonomic inputs to the sinoatrial node while preserving its intrinsic function. The intervention is performed via video-assisted thoracoscopic surgery (VATS) and targets the epicardial autonomic ganglia and neural connections responsible for inappropriate sinus tachycardia or autonomic dysfunction. Unlike traditional sinus node modification, this approach avoids direct ablation of the sinus node and focuses on surrounding autonomic structures. The goal is to reduce pathologic chronotropic activity and improve symptom control without inducing iatrogenic bradycardia.

PROCEDURE

Cardiac sympathetic denervation

Cardiac sympathetic denervation is an interventional procedure aimed at reducing excessive sympathetic drive to the heart by ablating or removing components of the sympathetic nervous system. It is typically performed via a thoracoscopic approach and involves bilateral or left-sided denervation of the stellate ganglion and thoracic sympathetic chain (usually T2-T4). CSD is used in patients with arrhythmias associated with sympathetic overactivity, such as long QT syndrome, catecholaminergic polymorphic ventricular tachycardia (CPVT), or autonomic dysfunction-related tachyarrhythmias. The procedure helps reduce arrhythmic burden, modulate autonomic tone, and improve symptom control.

BEHAVIORAL

Hybrid Cardiac Rehabilitation Program

A two-phase program combining supervised inpatient exercise, respiratory training, psychological support, and education with a home-based telerehabilitation phase (Nordic walking, remote ECG and vital sign monitoring). The aim is to restore functional capacity, reduce symptoms, and improve autonomic balance.

DEVICE

Transcutaneous Vagus Nerve Stimulation (tVNS)

Transcutaneous vagus nerve stimulation (tVNS) is a non-invasive neuromodulation technique in which the vagus nerve is stimulated via surface electrodes placed on the skin, most commonly in the auricular region (e.g., tragus or cymba conchae). The intervention is performed using a certified external stimulation device that delivers mild electrical impulses to activate afferent vagal fibers. tVNS is used in the treatment of various conditions, including depression, epilepsy, migraine, chronic pain, and disorders of the autonomic nervous system such as postural orthostatic tachycardia syndrome (POTS) and inappropriate sinus tachycardia (IST). In this study, tVNS is applied as a supportive neuromodulatory therapy with individualized stimulation parameters and session duration based on clinical response and patient tolerance.

Trial Locations (1)

Unknown

RECRUITING

SabaMed, Rzeszów

All Listed Sponsors
lead

SABAMED Medical Center Ltd.

NETWORK