NCT07196397Recruiting
POLish Registry of CArdioneuroablation and CArdioneuromodulation
POL-CA Registry: Multicenter Observational Study of Neuromodulatory Procedures in Cardiovascular Autonomic Dysfunction Syndromes
Source: ClinicalTrials.gov · Last updated 29 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 21 Sept 2025
- Start date
- 21 Nov 2024
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- SABAMED Medical Center Ltd.
- Diseases
- Coronary artery disease
- NCT number
- NCT07196397
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 21 Nov 2024 to the primary completion date, 31 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Permanent pacemaker or ICD implanted prior to enrollment
Other illness
- Structural heart disease requiring surgical intervention
- Severe psychiatric comorbidities impairing participation
Other
- Inability to complete follow-up assessments or questionnaires
- Participation in another interventional clinical trial
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SabaMed Coordinator of this site? Confirm its status | Rzeszów | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.