POLish Registry of CArdioneuroablation and CArdioneuromodulation

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.