An observational study in Vasovagal Syndrome VVS, Cardioinhibitory Carotid Sinus Syndrome CSS and Symptomatic Sinus Bradycardia SB or Atrioventricular Block AV, sponsored by SABAMED Medical Center Ltd.. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by SABAMED Medical Center Ltd. · Observational
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.
The study aims to include a group of at least 1,000 individuals, taking into account subgroups of patients with rare diseases involving fewer than 50 individuals (e.g., carotid sinus hypersensitivity or familial sinus bradycardia). Participants will be divided into three age groups: 18-40 years, 41-60 years, and over 60 years. These individuals will undergo procedures affecting innervation or modifying cardiovascular reflexes (cardioneuroablation or neuromodulation) due to ineffective pharmacological treatment or training methods. This group will also include patients who, according to guidelines, qualify for pacemaker implantation but declined the procedure.
The clinical trial protocol specifies inclusion and exclusion criteria. The protocol outlines the collection of various data, including traditional medical history (including contact information) and data related to the interventional treatment performed (including assessment of treatment efficacy and the occurrence of both perioperative and long-term complications). Additionally, the protocol includes the use of scales and questionnaires to evaluate patient symptoms and well-being, as well as an analysis of standard and non-standard verbal and non-verbal behaviors of patients. Scales and questionnaires used to assess patient symptoms and well-being: EQ-5D, SF-36, VASIS for bradycardia symptoms (daytime, before sleep, nighttime, and morning), and MALMO scoring test.
Patients will also routinely undergo physical performance evaluations (assessment using the Borg scale, HRR analysis, correlation of heart rate values during exercise before and after the procedure, 6MWT walk tests, and analysis of tele-rehabilitation outcomes).
Patient follow-up will be conducted at 1, 6, and 12 months post-procedure and then annually from 2024 to 2030, with ECG evaluations. The primary endpoint of the study is the spontaneous recurrence of symptoms that were present before the procedure affecting innervation and/or cardiovascular reflexes.
Enrolment in the POL-CA registry does not involve performing any additional invasive medical procedures on the patients.
The Single POL-CA Registry for a specific treatment technique will be managed by an appointed project leader. The project leader will be responsible for preparing a literature review, inclusion criteria, and clinical and electrophysiological characteristics of the given treatment technique. The project leader either becomes the first author of the publication or designates one. Physicians' participation in the project will be voluntary, with acceptance of audits or data verification at local centres. Patient personal data will only be accessible to the local investigator and will remain protected. The order of authorship for the publication will be determined based on the contributions of the other project participants (e.g., number of patients, manuscript preparation, data analysis).
The POL-CA online platform will include a standardized data creation panel for the project leader and the study's website. Data collection will comply with standard encryption, protection procedures, and the requirements of bioethics and scientific committees.
159 studies on the registry are indexed under Hypotension, Orthostatic; 35 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 100 across 37 observational studies indexed under Hypotension, Orthostatic.
Browse Hypotension, Orthostatic studies →This is the only study on the registry with SABAMED Medical Center Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of at least one of the following conditions:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: cardioneuroablation · Behavioral: Hybrid Cardiac Rehabilitation Program
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.
Procedure: SN sparing hybrid ablation · Behavioral: Hybrid Cardiac Rehabilitation Program · Device: Transcutaneous Vagus Nerve Stimulation (tVNS)
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.
Procedure: Cardiac sympathetic denervation · Behavioral: Hybrid Cardiac Rehabilitation Program
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.
Procedure: cardioneuroablation · Procedure: SN sparing hybrid ablation · Procedure: Cardiac sympathetic denervation · Behavioral: Hybrid Cardiac Rehabilitation Program · Device: Transcutaneous Vagus Nerve Stimulation (tVNS)
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.
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 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.
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) 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.
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
Plan to share: No — Individual participant data (IPD) will not be shared because the registry collects sensitive clinical information on rare cardiovascular autonomic disorders. Only aggregated, de-identified summary results will be reported in scientific publications and presentations. Access to raw patient-level data will remain restricted to local investigators in compliance with GDPR and bioethics committee requirements.
Started Nov 2024 (actual). Primary completion is estimated for Dec 2030, 73 months after the start.
Of 21 observational studies under Hypotension, Orthostatic, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 56. This study's planned 73 months is above that.
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