POLish Registry of CArdioneuroablation and CArdioneuromodulation

NCT07196397 | Recruiting

• 1 other identifier: 51/2024/В
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vasovagal Syndrome VVS; Cardioinhibitory Carotid Sinus Syndrome CSS; Symptomatic Sinus Bradycardia SB or Atrioventricular Block AV; Postural Orthostatic Tachycardia Syndrome POTS; Orthostatic Hypotension; Inappropriate Sinus Tachycardia Syndrome IST; Vasospastic Angina; Microvascular Angina; Ventricular Arrythmia; Raynaud Phenomena; Autonomic Dysfunction; Autonomic Diseases

Keywords

cardioneuroablation; cardiac sympathetic denervation; sinoatrial node sparing hybrid ablation; catheter ablation; neural stimulation; cardioneuromodulation; percutaneus stellate ganglion blockage; cardiac rehabilitation; cardiovascular autonomic tests; syncope

Outcome Measures

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.

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

Study Arms (4)

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.

Procedure: cardioneuroablation; Behavioral: Hybrid Cardiac Rehabilitation Program

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.

Procedure: SN sparing hybrid ablation; Behavioral: Hybrid Cardiac Rehabilitation Program; Device: Transcutaneous Vagus Nerve Stimulation (tVNS)

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.

Procedure: Cardiac sympathetic denervation; Behavioral: Hybrid Cardiac Rehabilitation Program

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.

Procedure: cardioneuroablation; Procedure: SN sparing hybrid ablation; Procedure: Cardiac sympathetic denervation; Behavioral: Hybrid Cardiac Rehabilitation Program; Device: Transcutaneous Vagus Nerve Stimulation (tVNS)

Interventions

cardioneuroablation PROCEDURE

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.

other rare subgroups and neuromodulation intervention; vagally mediated bradycardia

SN sparing hybrid ablation PROCEDURE

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.

IST/POTS; other rare subgroups and neuromodulation intervention

Cardiac sympathetic denervation PROCEDURE

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.

Cardiac sympathetic denervation; other rare subgroups and neuromodulation intervention

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.

Cardiac sympathetic denervation; IST/POTS; other rare subgroups and neuromodulation intervention; vagally mediated bradycardia

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.

IST/POTS; other rare subgroups and neuromodulation intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• SABAMED Medical Center Ltd.: lead

Study Sites (1)

SabaMed

Rzeszów, Poland

RECRUITING

Related Publications (15)

• Ahmed A, Charate R, Bawa D, Ghazal R, Garg J, Pothineni NVK, Kabra R, Della Rocca DG, Atkins D, Lakkireddy P, Bommana S, Al-Ahmad A, Shenthar J, Padmanabhan D, Narasimhan C, DiBiase L, Romeya A, Gopinathannair R, Natale A, Lakkireddy D. Bilateral Cardiac Sympathetic Denervation for Refractory Multifocal Premature Ventricular Contractions in Patients With Nonischemic Cardiomyopathy. JACC Clin Electrophysiol. 2024 Jan;10(1):31-39. doi: 10.1016/j.jacep.2023.09.014. Epub 2023 Nov 8.

  PMID: 37943190 BACKGROUND

• Stec S, Kuteszko R, Sulik A, Kornaszewska M. Double trouble: Hybrid management of inappropriate sinus tachycardia and sinus bradycardia in the era of cardioneuromodulation. HeartRhythm Case Rep. 2025 Aug 16;11(11):1151-1156. doi: 10.1016/j.hrcr.2025.08.012. eCollection 2025 Nov. No abstract available.

  PMID: 41333861 BACKGROUND

• Kornaszewska M, Wilczek-Banc A, Ratajska A, Piotrowicz E, Szkaradek B, Kowalewski M, Suwalski P, Ogorzelec N, Wileczek A, Zajac M, Pastyrzak M, Stec S. Implementation of a Hybrid Cardiac Rehabilitation and Symptom Scoring System in Patients with Inappropriate or Postural Sinus Tachycardia Referred for Sinus Node Sparing Hybrid Ablation. J Clin Med. 2025 Aug 20;14(16):5879. doi: 10.3390/jcm14165879.

  PMID: 40869705 BACKGROUND

• Stec S, Suwalski P, de Asmundis C, La Meir M, Reichert A, Wilczek-Banc A, Szkaradek B, Kowalewski M. EP-Heart Team approach with sinus node sparing ablation for complex inappropriate sinus tachycardia and postural orthostatic tachycardia syndrome: A first experience in Central Europe. Kardiol Pol. 2025;83(3):342-344. doi: 10.33963/v.phj.103819. Epub 2025 Jan 2. No abstract available.

  PMID: 39743902 BACKGROUND

• de Asmundis C, Pannone L, Lakkireddy D, Beaver TM, Brodt CR, Lee RJ, Frazier K, Chierchia GB, La Meir M. Hybrid epicardial and endocardial sinus node-sparing ablation therapy for inappropriate sinus tachycardia: Rationale and design of the multicenter HEAL-IST IDE trial. Heart Rhythm O2. 2023 Jan 31;4(4):275-282. doi: 10.1016/j.hroo.2023.01.005. eCollection 2023 Apr.

  PMID: 37124558 BACKGROUND

• Lakkireddy D, Garg J, DeAsmundis C, LaMeier M, Romeya A, Vanmeetren J, Park P, Tummala R, Koerber S, Vasamreddy C, Shah A, Shivamurthy P, Frazier K, Awasthi Y, Chierchia GB, Atkins D, Bommana S, Di Biase L, Al-Ahmad A, Natale A, Gopinathannair R. Sinus Node Sparing Hybrid Thoracoscopic Ablation Outcomes in Patients with Inappropriate Sinus Tachycardia (SUSRUTA-IST) Registry. Heart Rhythm. 2022 Jan;19(1):30-38. doi: 10.1016/j.hrthm.2021.07.010. Epub 2021 Jul 30.

  PMID: 34339847 BACKGROUND

• Aksu T, Brignole M, Calo L, Debruyne P, Di Biase L, Deharo JC, Fanciulli A, Fedorowski A, Kulakowski P, Morillo C, Moya A, Piotrowski R, Stec S, Sutton R, van Dijk JG, Wichterle D, Tse HF, Yao Y, Sheldon RS, Vaseghi M, Pachon JC, Scanavacca M, Meyer C, Amin R, Gupta D, Magnano M, Malik V, Schauerte P, Shen WK, Acosta JCZ. Cardioneuroablation for the treatment of reflex syncope and functional bradyarrhythmias: A Scientific Statement of the European Heart Rhythm Association (EHRA) of the ESC, the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS) and the Latin American Heart Rhythm Society (LAHRS). Europace. 2024 Aug 3;26(8):euae206. doi: 10.1093/europace/euae206.

  PMID: 39082698 BACKGROUND

• Kulakowski P, Baran J, Sikorska A, Krynski T, Niedzwiedz M, Soszynska M, Piotrowski R. Cardioneuroablation for reflex asystolic syncope: Mid-term safety, efficacy, and patient's acceptance. Heart Rhythm. 2024 Mar;21(3):282-291. doi: 10.1016/j.hrthm.2023.11.022. Epub 2023 Nov 29.

  PMID: 38036236 BACKGROUND

• Piotrowski R, Baran J, Sikorska A, Krynski T, Kulakowski P. Cardioneuroablation for Reflex Syncope: Efficacy and Effects on Autonomic Cardiac Regulation-A Prospective Randomized Trial. JACC Clin Electrophysiol. 2023 Jan;9(1):85-95. doi: 10.1016/j.jacep.2022.08.011. Epub 2022 Aug 28.

  PMID: 36114133 BACKGROUND

• Pachon JC, Pachon EI, Pachon JC, Lobo TJ, Pachon MZ, Vargas RN, Jatene AD. "Cardioneuroablation"--new treatment for neurocardiogenic syncope, functional AV block and sinus dysfunction using catheter RF-ablation. Europace. 2005 Jan;7(1):1-13. doi: 10.1016/j.eupc.2004.10.003.

  PMID: 15670960 BACKGROUND

• Tomasiewicz K, Woron J, Kobayashi A, Krasinski Z, Rydzewska G, Szymanski FM. Post-COVID-19 syndrome in everyday clinical practice: interdisciplinary expert position statement endorsed by the Polish Society of Civilization Diseases. Pol Arch Intern Med. 2024 May 28;134(5):16728. doi: 10.20452/pamw.16728. Epub 2024 Apr 15.

  PMID: 38619233 BACKGROUND

• Spahic JM, Hamrefors V, Johansson M, Ricci F, Melander O, Sutton R, Fedorowski A. Malmo POTS symptom score: Assessing symptom burden in postural orthostatic tachycardia syndrome. J Intern Med. 2023 Jan;293(1):91-99. doi: 10.1111/joim.13566. Epub 2022 Sep 16.

  PMID: 36111700 BACKGROUND

• Kusumoto FM, Schoenfeld MH, Barrett C, Edgerton JR, Ellenbogen KA, Gold MR, Goldschlager NF, Hamilton RM, Joglar JA, Kim RJ, Lee R, Marine JE, McLeod CJ, Oken KR, Patton KK, Pellegrini CN, Selzman KA, Thompson A, Varosy PD. 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2019 Aug 20;74(7):e51-e156. doi: 10.1016/j.jacc.2018.10.044. Epub 2018 Nov 6. No abstract available.

  PMID: 30412709 BACKGROUND

• Brignole M, Moya A, de Lange FJ, Deharo JC, Elliott PM, Fanciulli A, Fedorowski A, Furlan R, Kenny RA, Martin A, Probst V, Reed MJ, Rice CP, Sutton R, Ungar A, van Dijk JG; ESC Scientific Document Group. Practical Instructions for the 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018 Jun 1;39(21):e43-e80. doi: 10.1093/eurheartj/ehy071. No abstract available.

  PMID: 29562291 BACKGROUND

• Ajijola OA, Aksu T, Arora R, Biaggioni I, Chen PS, De Ferrari G, Dusi V, Fudim M, Goldberger JJ, Green AL, Herring N, Khalsa SS, Kumar R, Lakatta E, Mehra R, Meyer C, Po S, Stavrakis S, Somers VK, Tan AY, Valderrabano M, Shivkumar K. Clinical neurocardiology: defining the value of neuroscience-based cardiovascular therapeutics - 2024 update. J Physiol. 2025 Mar;603(7):1781-1839. doi: 10.1113/JP284741. Epub 2025 Mar 8.

  PMID: 40056025 BACKGROUND

MeSH Terms

Conditions

Hypotension, Orthostatic; Angina Pectoris, Variant; Microvascular Angina; Primary Dysautonomias; Autonomic Nervous System Diseases; Syncope

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases; Angina, Unstable; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations

Study Officials

• Sebastian Stec, Prof., MD, PhD

  SABAMED Medical Center Ltd.

  PRINCIPAL INVESTIGATOR

• Marta Kornaszewska, MD

  SABAMED Medical Center Ltd.

  STUDY DIRECTOR

Central Study Contacts

Sebastian Stec, Prof., MD, PhD

CONTACT

+48600298022; smstec@wp.pl

Marta Kornaszewska, MD

CONTACT

+48881340342; mkornaszewska@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: September 29, 2025
• Study Start: November 21, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)