POLish Registry of CArdioneuroablation and CArdioneuromodulation (NCT07196397) | Clinical Trial Compass
RecruitingNot Applicable
POLish Registry of CArdioneuroablation and CArdioneuromodulation
Poland1,000 participantsStarted 2024-11-21
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Recurrence of Pre-Treatment Autonomic Symptoms at 12 Months
Timeframe: Baseline and 1, 6, and 12 months post-intervention