RecruitingNCT07196397

POLish Registry of CArdioneuroablation and CArdioneuromodulation

POL-CA Registry: Multicenter Observational Study of Neuromodulatory Procedures in Cardiovascular Autonomic Dysfunction Syndromes


Sponsor

SABAMED Medical Center Ltd.

Enrollment

1,000 participants

Start Date

Nov 21, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria11

  • Age ≥ 18 years
  • Diagnosis of at least one of the following conditions:
  • Inappropriate sinus tachycardia (IST)
  • Postural orthostatic tachycardia syndrome (POTS)
  • Vasovagal syncope (VVS)
  • Cardioinhibitory carotid sinus syndrome (CSS)
  • Symptomatic sinus bradycardia or functional AV block
  • Orthostatic hypotension (OH)
  • History of recurrent autonomic symptoms (e.g., syncope, bradycardia, palpitations, orthostatic intolerance)
  • Undergoing or previously underwent interventional treatment affecting cardiac autonomic innervation (e.g., cardioneuroablation, SN-sparing ablation, cardiac sympathetic denervation)
  • Provided written informed consent (for prospective arm)

Exclusion Criteria5

  • 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
  • Participation in another interventional clinical trial

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Interventions

PROCEDUREcardioneuroablation

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.

PROCEDURESN 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.

PROCEDURECardiac 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.

BEHAVIORALHybrid 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.

DEVICETranscutaneous 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.


Locations(1)

SabaMed

Rzeszów, Poland

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NCT07196397