Status:
UNKNOWN
Cardioneuroablation Versus Pacemaker Implantation for the Treatment of Symptomatic Sinus Node Dysfunction
Lead Sponsor:
Hospital Clinico Universitario de Santiago
Collaborating Sponsors:
Spanish Society of Cardiology
Hospital Universitario Lucus Augusti
Conditions:
Sinus Node Dysfunction
Sick Sinus Syndrome
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
Endocardial ganglion plexus ablation (cardioneuroablation) represents a promising therapeutic technique for the treatment of vasovagal syncope (VV), functional atrioventricular block (AVB) and sinus n...
Detailed Description
Sinus node dysfunction (SND), also known as sick sinus syndrome, comprises a wide spectrum of sinoatrial dysfunctions, ranging from sinus bradycardia, sinoatrial block, and sinus arrest to bradycardia...
Eligibility Criteria
Inclusion
- Symptomatic sinus node dysfunction (dizziness, asthenia or syncope) clearly related to an abnormal electrocardiogram finding (sinus arrest, sinoatrial block, extreme bradycardia (\<40 bpm) or chronotropic incompetence in the exercise test).
- Absence of structural cardiopathy
Exclusion
- Left ventricular ejection fraction \<50%
- Severe valvular disease
- Any type of cardiomyopathy such as hypertrophic cardiomyopathy
- Previous ischemic heart disease
- QRS interval \>130 ms
- Atrioventricular conduction disorder with a former indication of pacemaker implantation (atrioventricular block Mobitz II, advanced atrioventricular block, complete atrioventricular block)
- Lifetime expectance \<12 months
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05186220
Start Date
November 1 2021
End Date
November 1 2023
Last Update
January 11 2022
Active Locations (1)
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1
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain, 15706