Clinical trial NCT05196126: Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction
Official title: Comparison of Strategies for Permanent Pacemaker Implantation and/or Cardioneuroablation in Patients With Sinus Node Dysfunction: a Noncommercial Physician-initiated Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sinus Node Dysfunction
Keywords: cardioneuroablation
pacemaker
sinus node dysfunction
bradycardia
extracardiac vagal nerve stimulation
ECG monitoring
quality of life
Lead sponsor: Stec, Sebastian, MD, PhD, FESC
Sponsor class: OTHER
Collaborators: name: KCRI
First posted: 2022-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 medical products applied for invasive and nonivasive procedures performed at the participating centers.

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 protocol. After speaking to the investigator and receiving detailed answers to all questions, the patient will sign the written informed consent form to participate in the study or will choose to opt out of randomization and to be included in the registry only.

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).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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 )

Primary outcomes:
measure: Number of Participants Who Had Freedom From Bradycardia Symptoms at 6 months
timeFrame: 6 months
measure: Number of Participants with Pacemaker Implantation at 6 months
timeFrame: 6 monhts
Secondary outcomes:
measure: Number of Events of Procedural Complications
timeFrame: 0-6 months
measure: Number of Participants With Post-ablation Inducibility of Sinus Arrest and/or AV Block by Vagal Nerve Stimulation
timeFrame: 1 day (peri-procedural)
measure: Effect of CNA on Quality of Life Parameters Based on EQ-5D-5L Questionnaire
timeFrame: 0, 3, 6, 9, 12 months
measure: Effect of CNA on Quality of Life Parameters Based on SF-36 Questionnaire
timeFrame: 0, 3, 6, 9, 12 months
measure: Effect of CNA on Fatigue Based on Modified Fatigue Impact Scale (MFIS)
timeFrame: 0, 6, 12 months
measure: Effect of CNA on Depression/Anxiety based on Modified Hospital Anxiety and Depression Scale (HADS-M)
timeFrame: 0, 6, 12 months
measure: Effect of CNA on Sleep Disorders Based on Epworth Sleep Scale (ESS)
timeFrame: 0, 6, 12 months
measure: Effect of CNA on Sleep Disorders Based on Athens Insomnia Scale-8 (AIS-8)
timeFrame: 0, 6, 12 months
Other outcomes:
Locations:
city: Ostrowiec Świętokrzyski
country: Poland
facility: Center of Interventional Cardiology, Electrotherapy and Angiology G.V.M. Carint
city: Rzeszów
country: Poland
facility: Medical Center SABAMED
city: Sanok
country: Poland
facility: Subcarpatian Center for Cardiovascular Interventions, Laboratory of Electrophysiology, Cardioneuroablation, Ablation, Arrhythmia and Heart Electrostimulation, G.V.M. Carint
city: Wroclaw
country: Poland
facility: Department of Cardiology, Laboratory of Invasive Electrophysiology, 4th Military Teaching Hospital in Wroclaw
Study officials:
affiliation: Medical Center SABAMED Medicans
name: Sebastian Stec, MD, PhD
role: STUDY_CHAIR
References: