POL-CA Registry Observational Study of Neuromodulatory Treatments for Autonomic Heart Conditions

What this Trial Is About

This research investigates a wide range of patients with histories of fainting syncope and autonomic dysfunction syndromes such as vasovagal syndrome, cardioinhibitory carotid sinus syndrome, symptomatic sinus bradycardia or atrioventricular block, postural orthostatic tachycardia syndrome, orthostatic hypotension, and inappropriate sinus tachycardia syndrome. The study aims to create a comprehensive registry to analyze treatment outcomes and population characteristics by collecting standardized data from patients who undergo neuromodulatory procedures affecting heart innervation and cardiovascular reflexes. These procedures are studied in patients who have not responded to medications or training, including those who declined pacemaker implantation. Participants will be grouped by age and condition and may have undergone procedures like cardioneuroablation, sinus node-sparing ablation, cardiac sympathetic denervation, or neuromodulatory therapies such as transcutaneous vagus nerve stimulation and hybrid cardiac rehabilitation. These interventions aim to modify autonomic nervous system inputs to improve symptoms related to abnormal heart rate and rhythm. The study collects detailed clinical and treatment data, including patient symptoms, well-being, and physical performance measures. Participants will be followed up at 1, 6, and 12 months after the procedure and then annually through 2030, with evaluations including ECGs, symptom questionnaires, and physical tests like the 6-minute walk test. The primary measurement is the recurrence of symptoms present before the neuromodulatory treatment. Data security and confidentiality are maintained throughout the study, and no additional invasive procedures are performed solely for the registry participation.

POLish Registry of CArdioneuroablation and CArdioneuromodulation