Polish registry of heart nerve–targeting treatments (cardioneuroablation and cardioneuromodulation)
POL-CA Registry: Multicenter Observational Study of Neuromodulatory Procedures in Cardiovascular Autonomic Dysfunction Syndromes
This registry collects information to see how nerve-targeting heart procedures work for adults with fainting, abnormal heart rhythms, or orthostatic problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | SABAMED Medical Center Ltd. Research network |
| Locations | 1 site (Rzeszów) |
| Trial ID | NCT07196397 on ClinicalTrials.gov |
What this trial studies
POL-CA is a multicenter observational registry combining retrospective and prospective data on adults who have undergone or will undergo procedures that modify cardiac autonomic innervation, such as cardioneuroablation, sinoatrial-node-sparing hybrid ablation, and cardiac sympathetic denervation. The registry aims to enroll at least 1,000 participants across three age groups and to standardize data collection with a common POL-CA questionnaire and methodology. Data collected include clinical history, procedural details, perioperative and long-term complications, and patient-reported outcomes using EQ-5D, SF-36, VASIS, and MALMO scales. The goal is to provide a multicenter summary of patient characteristics, treatment patterns, and real-world outcomes for a spectrum of autonomic cardiac disorders.
Who should consider this trial
Good fit: Adults (≥18 years) with diagnoses such as vasovagal syncope, POTS, inappropriate sinus tachycardia, cardioinhibitory carotid sinus syndrome, symptomatic sinus bradycardia or functional AV block, or orthostatic hypotension who have undergone or are planned for cardioneuroablation, SN-sparing ablation, cardiac sympathetic denervation, or similar neuromodulation procedures are eligible.
Not a fit: Patients with structural heart disease requiring surgical intervention, those with a preexisting permanent pacemaker or ICD, individuals unable to complete follow-up or questionnaires, and those with severe psychiatric comorbidities are unlikely to benefit from participation in this registry.
Why it matters
Potential benefit: If successful, the registry could help doctors identify which patients benefit most from nerve-targeting heart procedures and improve treatment decisions and follow-up care.
How similar studies have performed: Smaller observational series and case reports have shown promising symptom improvements after cardioneuroablation and neuromodulation, but randomized controlled evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Where this trial is running
Rzeszów
- SabaMed — Rzeszów, Poland (Recruiting)
Study contacts
- Principal investigator: Sebastian Stec, Prof., MD, PhD — SABAMED Medical Center Ltd.
- Study coordinator: Sebastian Stec, Prof., MD, PhD
- Email: smstec@wp.pl
- Phone: +48600298022
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.