POLish Registry of CArdioneuroablation and CArdioneuromodulation

Recruiting now

Conditions studied: Vasovagal Syndrome VVS, Cardioinhibitory Carotid Sinus Syndrome CSS, Symptomatic Sinus Bradycardia SB or Atrioventricular Block AV, Postural Orthostatic Tachycardia Syndrome POTS, Orthostatic Hypotension, Inappropriate Sinus Tachycardia Syndrome IST, Vasospastic Angina, Microvascular Angina, Ventricular Arrythmia, Raynaud Phenomena, Autonomic Dysfunction, Autonomic Diseases

In brief

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.

Key facts

Study ID

NCT07196397

Run by

SABAMED Medical Center Ltd.

People needed

1000

Starts

2024-11-21

Expected to finish

2031-12-31

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 is running

• SabaMed — Rzeszów, Poland (enrolling)

Full record on ClinicalTrials.gov

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