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

Status: Recruiting

Location: See location...

Intervention Type: Procedure, Behavioral, Device

Study Type: Observational

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

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• 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)

Locations

Other Locations

Poland

SabaMed

RECRUITING

Rzeszów

Contact Information

Primary

Sebastian Stec, Prof., MD, PhD

smstec@wp.pl

+48600298022

Backup

Marta Kornaszewska, MD

mkornaszewska@gmail.com

+48881340342

Time Frame

Start Date: 2024-11-21

Estimated Completion Date: 2031-12-31

Participants

Target number of participants: 1000

Treatments

vagally mediated bradycardia

This cohort includes patients with vagally mediated bradycardia, including cardioinhibitory vasovagal syncope, carotid sinus syndrome, or functional sinus node dysfunction related to excessive parasympathetic activation. Patients are referred for interventional treatment due to recurrent syncope or symptomatic bradycardia refractory to conservative management. Interventions include cardioneuroablation or autonomic modulation procedures aimed at reducing vagal influence on the sinus and atrioventricular nodes while preserving physiological autonomic balance. Diagnosis is confirmed based on tilt-table testing, ECG documentation, and symptom correlation.

IST/POTS

This cohort includes patients diagnosed with inappropriate sinus tachycardia (IST) or postural orthostatic tachycardia syndrome (POTS) who are undergoing interventional treatment due to insufficient response to pharmacological or behavioral therapy. Interventions include sinus node-sparing thoracoscopic ablation aimed at improving symptoms and quality of life. Autonomic dysfunction is confirmed based on standardized testing, and the interventions target neural pathways involved in excessive sympathetic or inadequate parasympathetic control of heart rate and vascular tone.

Cardiac sympathetic denervation

Patients with clinical indications for stand-alone or concomittant, hybrid cardiac sympathetic denervation. This cohort includes patients with arrhythmias driven by excessive sympathetic activation, such as congenital long QT syndrome (LQTS), catecholaminergic polymorphic ventricular tachycardia (CPVT), and refractory ventricular tachyarrhythmias. Patients are referred for cardiac sympathetic denervation (CSD) due to high arrhythmic burden despite optimal pharmacologic treatment or recurrent implantable cardioverter-defibrillator (ICD) shocks. CSD is performed via thoracoscopic access and involves ablation or removal of the stellate ganglion and thoracic sympathetic chain (typically T2-T4). The goal is to reduce sympathetic drive, stabilize cardiac electrophysiology, and prevent life-threatening arrhythmias.

other rare subgroups and neuromodulation intervention

This cohort includes patients with rare autonomic or electrophysiological syndromes undergoing neuromodulatory interventions as part of individualized treatment strategies. Interventions may include transcutaneous vagus nerve stimulation (tVNS), structured cardiac rehabilitation programs with autonomic modulation components, and other non-invasive or minimally invasive techniques aimed at improving autonomic balance and symptom burden. This group is characterized by heterogeneous diagnoses, including overlapping or atypical forms of autonomic dysfunction, and is managed with a personalized, multidisciplinary approach integrating physiologic monitoring, rehabilitation, and neuromodulation.

Related Therapeutic Areas

Chronic Pain

Low Blood Pressure

Familial Dysautonomia

Inappropriate Sinus Tachycardia (IST)

Ventricular Tachycardia

Postural Orthostatic Tachycardia Syndrome (POTS)

Migraine

Orthostatic Hypotension

Arrhythmias

Fainting

Long QT Syndrome