Status:
UNKNOWN
Safety and Efficacy of His Bundle Pacing Validated by Extracardiac Vagal Nerve Stimulation
Lead Sponsor:
4th Military Clinical Hospital with Polyclinic, Poland
Collaborating Sponsors:
Subcarpathian Center for Cardiovascular Intervention
Mazovian Speciality Hospital
Conditions:
Permanent His Bundle Pacing
Permanent Left Bundle Branch Pacing
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Different studies for extracardiac vagal nerve stimulation (ECANS) have been published and confirmed the influence of the vagus nerve on automaticity and conduction properties of the sinus node, atria...
Detailed Description
This is a multicenter, prospective, open-label, randomized, interventional study enrolling patients with indications for permanent cardiac pacing according to the current European Society of Cardiolog...
Eligibility Criteria
Inclusion
- signed informed consent form
- effective and stable HB or LBB pacing
- sinus rhythm during the intervention procedure
Exclusion
- contraindications to invasive EPS
- contraindications to general anesthesia
- contraindications to atropine administration (e.g., glaucoma)
- persistent atrial fibrillation or atrial flutter
- pregnancy
- diseases that may cause autonomic system neuropathy
- use of medications that may affect the parasympathetic system
- a history of cardiac surgery
- a history of ablation due to arrhythmia
Key Trial Info
Start Date :
January 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04816864
Start Date
January 2 2021
End Date
December 31 2023
Last Update
December 20 2022
Active Locations (3)
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1
4th Military Hospital, Cardiology Department
Wroclaw, Lower Silesian Voivodeship, Poland, 50-981
2
Mazovian Speciality Hospital, Cardiology Department
Radom, Masovian Voivodeship, Poland, 26-617
3
Subcarpathian Center for Cardiovascular Intervention
Sanok, Podkarpackie Voivodeship, Poland, 38-500