Status:
RECRUITING
POLish Registry of CArdioneuroablation and CArdioneuromodulation
Lead Sponsor:
SABAMED Medical Center Ltd.
Conditions:
Vasovagal Syndrome VVS
Cardioinhibitory Carotid Sinus Syndrome CSS
Eligibility:
All Genders
18+ years
Brief 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...
Detailed Description
The study aims to include a group of at least 1,000 individuals, taking into account subgroups of patients with rare diseases involving fewer than 50 individuals (e.g., carotid sinus hypersensitivity ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 21 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT07196397
Start Date
November 21 2024
End Date
December 31 2031
Last Update
September 29 2025
Active Locations (1)
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1
SabaMed
Rzeszów, Poland