Polish registry of heart nerve–targeting treatments (cardioneuroablation and cardioneuromodulation)
Official title: POL-CA Registry: Multicenter Observational Study of Neuromodulatory Procedures in Cardiovascular Autonomic Dysfunction Syndromes
Run by SABAMED Medical Center Ltd. · NCT07196397 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | SABAMED Medical Center Ltd. Research network |
| Locations | 1 site (Rzeszów) |
| Status | Recruiting |
| Started | November 21, 2024 |
| Main results expected | December 31, 2030 |
| Study ends | December 31, 2031 |
| Registry record updated | September 29, 2025 |
| Trial ID | NCT07196397 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Smaller observational series and case reports have shown promising symptom improvements after cardioneuroablation and neuromodulation, but randomized controlled evidence is still limited.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.