Status:
UNKNOWN
Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction
Lead Sponsor:
Stec, Sebastian, MD, PhD, FESC
Collaborating Sponsors:
KCRI
Conditions:
Sinus Node Dysfunction
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a noncommercial, physician-initiated, monitored, multicenter, prospective randomized clinical trial, a proof-of-concept study, investigating a treatment strategy only. The study will use medic...
Detailed Description
All patients meeting the inclusion criteria and not meeting the exclusion criteria will be invited to participate in the study. The patient will receive an informed consent form describing the study p...
Eligibility Criteria
Inclusion
- Age, 18-75 years
- Sinus node dysfunction/disease fulfilling criteria for elective pacemaker implantation according to current ESC guidelines (I, IIa, and IIb )
- Optimization of chronic disease treatment
- Ability to provide informed consent to participate in the study
- Ability to understand patient information.
Exclusion
- Contraindications to invasive and noninvasive procedures used in the study
- Uncontrolled endocrine and systemic disorders
- Persistent atrial fibrillation
- Dilated cardiomyopathy
- Severe congenital heart valve disease or cardiomyopathy
- Functional NYHA class III/IV
- Left ventricular ejection fraction \<35%
- Left atrial diameter \>50 mm
- Previous catheter ablation
- Contraindications to anticoagulant treatment
- Contraindications to catheter ablation
- Chronic, advanced two- or third-degree atrioventricular block associated with structural heart disease
- Contraindications to noninvasive tests
- Pregnancy and lactation
- Previous cardiac surgery
- Implanted pacemaker device
- Neck and chest abnormalities
- Myocardial infarction in the previous 6 months
- Percutaneous coronary intervention in the previous 3 months
- Estimated survival \<24 months
- Participation in another drug or medical device program
- Limited capacity to understand the study protocol or psychological disorders precluding informed consent to participate in the study.
- Any other uncontrolled chronic diseases, neck and chest abnormalities, or disorders that constitute a contraindication to catheter ablation, antiarrhytmic treatment, general anesthesia, or extracardiac vagal nerve stimulation (ECANS)
- Severe obesity (body mass index ≥40 kg/m2 )
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05196126
Start Date
June 1 2022
End Date
June 30 2024
Last Update
March 7 2023
Active Locations (4)
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1
Center of Interventional Cardiology, Electrotherapy and Angiology G.V.M. Carint
Ostrowiec Świętokrzyski, Poland, 27-400
2
Medical Center SABAMED
Rzeszów, Poland
3
Subcarpatian Center for Cardiovascular Interventions, Laboratory of Electrophysiology, Cardioneuroablation, Ablation, Arrhythmia and Heart Electrostimulation, G.V.M. Carint
Sanok, Poland, 38-500
4
Department of Cardiology, Laboratory of Invasive Electrophysiology, 4th Military Teaching Hospital in Wroclaw
Wroclaw, Poland, 50-07