Cardioneuroablation: Fragmented Atrial Potentials, Intracardiac Echocardiography and Compu
Cardioneuroablation (CNA) is a new method for the treatment of asystolic reflex syncope, however, optimal methods for identification of presumed sites of ganglionated plexi (GP), which are the target for CNA and are located in the epicardial fat, have not yet been established. This study will compare the accuracy of th
| Condition(s) | Syncope, Vasovagal |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Cardioneuroablation (CNA) is a new method for the treatment of asystolic reflex syncope, however, optimal methods for identification of presumed sites of ganglionated plexi (GP), which are the target for CNA and are located in the epicardial fat, have not yet been established. This study will compare the accuracy of three methods used for identification of these areas: intracardiac recordings of fractionated atrial electrograms, intracardiac echocardiography and computed tomography. The study group will consist of 100 patients undergoing CNA in our institution. The procedure will be performed in a standard manner with the use of extracardiac vagal stimulation as the intraprocedural end-point. Correlation between the three methods used for localisation of optimal sites for CNA as well as th |
| Who can participate | Inclusion Criteria: * severe, recurrent symptoms due to reflex syncope with ECG documented asystole \>3 seconds, especially if associated with injury, or recurrent presyncope with persistent reflex bradycardia * history of ineffective prior non-pharmacological treatment and positive baseline atropine test (sinus rate acceleration \> 30% and no AV block following 2 mg of intravenous atropine) - * informed written consent obtained Exclusion Criteria: * contraindications to perform cardioneuroablation * contraindications to perform computed tomography with intravenous contrast injection * lack of informed written consent obtained |
| Ages | 14 Years |
| Sex | All |
| Lead sponsor | Centre of Postgraduate Medical Education |
| Locations | Warsaw, Masovian Voivodeship, Poland |
| Start date | 2024-05-20 |
| NCT ID | NCT06472102 |
| Official listing | https://clinicaltrials.gov/study/NCT06472102 |