POLish Registry of CArdioneuroablation and CArdioneuromodulation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSABAMED Medical Center Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Inappropriate sinus tachycardia (IST)

Postural orthostatic tachycardia syndrome (POTS)

Vasovagal syncope (VVS)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • cardioneuroablation
  • SN sparing hybrid ablation
  • Cardiac sympathetic denervation
  • Hybrid Cardiac Rehabilitation Program
  • Transcutaneous Vagus Nerve Stimulation (tVNS)

Treatment groups

1,000 Participants
are divided into 4 treatment groups

Sponsors and collaborators