Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction
NCT ID: NCT05196126
Last Updated: 2023-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2022-06-01
2024-06-30
Brief Summary
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Detailed Description
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Premenopausal women who will provide consent to participate in the study will undergo a pregnancy test before any invasive procedure. During the 12-month study duration, the use of effective contraception is recommended.
The patient will be asked to complete the questionnaires on bradycardia symptoms and quality of life (QOL).
Any patient included in the study will be randomized into group A or group B. Patients included in the registry (group C) will undergo patient-tailored interventions and treatments through shared decision-making with a possibility of permanent cardiac pacing (subgroup CA), vagal nerve stimulation (VNS) according to the protocol and cardioneuroablation (subgroup CB), as well as observation (subgroup CO).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A - PACEMAKER
According with ESC indications for elective pacemaker implantation due to SND will referred for PM implantation.
Permament pacemaker implantation
PM implantation
Group B - CARDIONEUROABLATION
According with ESC indications for elective PM implantation due to SND will referred for ICM/ILR implantation or prolonged ECG monitoring. Within 4 weeks patient will be screened by interdisciplinary team and autonomic tests (including atropine tests) will be performed. Than, based on atropine tests, electrophysiologic study and extracardiac vagal nerve stimulation, final indication for cardioneuroablation will be established. Biatrial, binodal cardioneuroablation will be performed with anatomical approach with bilateral extra cardiac vagal nerve stimulation during general anesthesia. Than, patient will be closely monitored and indication for PM implantation will be verified.
Cardioneuroablation
Biatrial, binodal CNA procedure with anatomical approach will be performed with pre- and post procedural extracardiac vagal nerve stimulation in general anesthesia.
Interventions
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Permament pacemaker implantation
PM implantation
Cardioneuroablation
Biatrial, binodal CNA procedure with anatomical approach will be performed with pre- and post procedural extracardiac vagal nerve stimulation in general anesthesia.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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 )
18 Years
75 Years
ALL
No
Sponsors
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KCRI
OTHER
Stec, Sebastian, MD, PhD, FESC
OTHER
Responsible Party
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Sebastian Stec
Stec Sebastian MD, PhD, FESC
Principal Investigators
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Sebastian Stec, MD, PhD
Role: STUDY_CHAIR
Medical Center SABAMED Medicans
Locations
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Center of Interventional Cardiology, Electrotherapy and Angiology G.V.M. Carint
Ostrowiec Świętokrzyski, , Poland
Medical Center SABAMED
Rzeszów, , Poland
Subcarpatian Center for Cardiovascular Interventions, Laboratory of Electrophysiology, Cardioneuroablation, Ablation, Arrhythmia and Heart Electrostimulation, G.V.M. Carint
Sanok, , Poland
Department of Cardiology, Laboratory of Invasive Electrophysiology, 4th Military Teaching Hospital in Wroclaw
Wroclaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SANOK
Identifier Type: -
Identifier Source: org_study_id
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