Status:
TERMINATED
Cardioneuroablation: Comparison of Right Versus Left Atrial Approach in Patients With Reflex Syncope
Lead Sponsor:
Centre of Postgraduate Medical Education
Conditions:
Reflex Syncope
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
Introduction. Reflex vaso-vagal syncope (VVS) is the most frequent cause of transient loss of consciousness and it's treatment remains a challenge. Cardioneuroablation (CNA) is a relatively new and pr...
Detailed Description
Introduction. Reflex vaso-vagal syncope (VVS) is the most frequent cause of transient loss of consciousness in general population. It markedly decreases quality of life and may lead to injury. The mec...
Eligibility Criteria
Inclusion
- 1\. Documented spontaneous or tilt-induced syncope with at least 3 seconds of asystole due to sinus arrest or AVB, refractory to standard non-pharmacological treatment.
- 2\. High syncope burden (\> 1 syncope per year or \> 3 presyncopal events during preceding 12 months) or very severe syncope in the past, leading to injury.
- 3\. Significantly decreased quality of life due to syncope (\>20 points in QoL questionnaire dedicated to patients with syncope \[17\]).
- 4\. Standard ECG and 24hr ambulatory ECG recorded within one month before procedure.
- 5\. Positive baseline atropine test defined as at least 30% increase in sinus rate compared with baseline value.
- 6\. Obtained written informed consent.
- 7\. Age \> 16 years
Exclusion
- 1\. Other possible and treatable causes of syncope such as orthostatic hypotension, IST, POTS, significant cardiac disease, cardiac arrhythmia or abnormalities of vertebrobasilar arteries
- 2\. History of stroke or TIA
- 3\. History of cardiac surgery
- 4\. Contraindications to ablation in the right or left atrium
Key Trial Info
Start Date :
February 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05225532
Start Date
February 2 2022
End Date
December 30 2022
Last Update
May 14 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital
Warsaw, Masovian Voivodeship, Poland, 04-073