POLish Registry of CArdioneuroablation and CArdioneuromodulation

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура cardioneuroablation
  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 prof
• Процедура SN 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 foc
• Процедура Cardiac 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 poly
• Поведенческое Hybrid 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.
• Устройство Transcutaneous 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

Первичные конечные точки

• Number of Participants with Recurrence of Pre-Treatment Autonomic Symptoms at 12 Months [Срок оценки: Baseline and 1, 6, and 12 months post-intervention]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Польша · 1 центр

• SabaMed — Rzeszów

Публикации

• 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 Elect PMID 37943190
• 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
• 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
• 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
• 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
• 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 PMID 34339847
• 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 brady PMID 39082698
• 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

Идентификаторы

NCT: NCT07196397 · 51/2024/В

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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