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POLish Registry of CArdioneuroablation and CArdioneuromodulation

ConditionsVasovagal 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
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSABAMED Medical Center Ltd.

About this trial

The multicentre observational study POL-CA involves a wide spectrum of patients with a history of syncopy. The study recruits patients with diagnosed vasovagal syndrome, cardioinhibitory carotid sinus syndrome, symptomatic sinus bradycardia or atrioventricular block, postural orthostatic tachycardia syndrome, orthostatic hypotension, and inappropriate sinus tachycardia syndrome. This is an observational, controlled study with retrospective, clinical data analysis of previously treated patients and the analysis of syncopal patients prospectively recruited into the study. The aim of the POL-CA registry is to create a platform for physicians to record treatment data for patients undergoing procedures that affect innervation or modify cardiovascular reflexes (cardioneuroablation, cardioneuromodulation) in order to provide a multicentre summary of population characteristics and treatment outcomes based on a standardized POL-CA questionnaire and methodology for various arrhythmias.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Inappropriate sinus tachycardia (IST)

Postural orthostatic tachycardia syndrome (POTS)

Vasovagal syncope (VVS)

Disqualifiers

Structural heart disease requiring surgical intervention

Permanent pacemaker or ICD implanted prior to enrollment

Inability to complete follow-up assessments or questionnaires

Severe psychiatric comorbidities impairing participation

Trial population

The study population includes adult patients aged 18 years and older with documented autonomic cardiovascular dysfunction, referred for or previously treated with procedures targeting cardiac innervation. The population includes both men and women, and covers a broad clinical spectrum including IST, POTS, VVS, CSS, sinus bradycardia, and orthostatic hypotension. Participants are enrolled across multiple centers in Poland. The study includes both retrospective and prospective cohorts.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • cardioneuroablation

    Procedure/Surgery

    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.

  • SN sparing hybrid ablation

    Procedure/Surgery

    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.

  • Cardiac sympathetic denervation

    Procedure/Surgery

    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.

  • Hybrid Cardiac Rehabilitation Program

    Behavioral

    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.

  • Transcutaneous Vagus Nerve Stimulation (tVNS)

    Device

    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.

Treatment groups

1,000 Participants
are divided into 4 treatment groups
Group A: vagally mediated bradycardia2 interventions
Group B: IST/POTS3 interventions
Group C: Cardiac sympathetic denervation2 interventions
Group D: other rare subgroups and neuromodulation intervention5 interventions

Trial outcomes

Primary outcomes

1

Number of Participants with Recurrence of Pre-Treatment Autonomic Symptoms at 12 Months

Recurrence is defined as the spontaneous return of autonomic symptoms (e.g., syncope, orthostatic intolerance, palpitations, bradycardia) that were present before the intervention. Symptoms are confirmed by clinical assessment, structured questionnaires (e.g., VASIS, MALMO, EQ-5D), and ECG data. This outcome will help evaluate the long-term effectiveness of autonomic modulation procedures.

Time frame
Baseline and 1, 6, and 12 months post-intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SABAMED Medical Center Ltd.

Lead sponsor

Source ClinicalTrials.gov
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