|

POLish Registry of CArdioneuroablation and CArdioneuromodulation

RECRUITINGSponsored by SABAMED Medical Center Ltd.
Actively Recruiting
SponsorSABAMED Medical Center Ltd.
Started2024-11-21
Est. completion2030-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07196397

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions13

Autonomic DiseasesAutonomic DysfunctionCardioinhibitory Carotid Sinus Syndrome CSSHeart DiseaseInappropriate Sinus Tachycardia Syndrome ISTMicrovascular AnginaOrthostatic HypotensionPostural Orthostatic Tachycardia Syndrome (POTS)Raynaud PhenomenaSymptomatic Sinus Bradycardia SB or Atrioventricular Block AV

Browse More Trials

Heart Disease trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.