Sinus Node Dysfunction Clinical Trial
— SANOKOfficial title:
Comparison of Strategies for Permanent Pacemaker Implantation and/or Cardioneuroablation in Patients With Sinus Node Dysfunction: a Noncommercial Physician-initiated Randomized Controlled Trial
NCT number | NCT05196126 |
Other study ID # | SANOK |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2022 |
Est. completion date | June 30, 2024 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 30, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 ) |
Country | Name | City | State |
---|---|---|---|
Poland | Center of Interventional Cardiology, Electrotherapy and Angiology G.V.M. Carint | Ostrowiec Swietokrzyski | |
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 |
Lead Sponsor | Collaborator |
---|---|
Stec, Sebastian, MD, PhD, FESC | KCRI |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Who Had Freedom From Bradycardia Symptoms at 6 months | Number of participants who had freedom from bradycardia symptoms at 6 months - for all participants - who had CNA versus PM implanation versus no procedure performed. Trial - patient is randomized to standard PM implatantion (Group A) or CNA procedure (Group B). Registry (Group C) - patient refused participation in the trial, and decided to have share-decision making procedure (CNA, PM implanatation) or no intervention at all - taking into account evidence, risk-benefit assesments, expected outcomes and individual patient preferences. | 6 months | |
Primary | Number of Participants with Pacemaker Implantation at 6 months | Number of participants with PM implantation at 6 months | 6 monhts | |
Secondary | Number of Events of Procedural Complications | Procedural Complications (death, stroke, myocardial infarction, heart failure, conduction abnormalities, pericardial effusion requiring drainage, hematoma, pseudoaneurysm (0-6 month changes) | 0-6 months | |
Secondary | Number of Participants With Post-ablation Inducibility of Sinus Arrest and/or AV Block by Vagal Nerve Stimulation | Number of participants with post-ablation inducibility of sinus arrest and/or AV block in pre- and post- procedural extracardiac Vagal Nerve stimulation | 1 day (peri-procedural) | |
Secondary | Effect of CNA on Quality of Life Parameters Based on EQ-5D-5L Questionnaire | EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is scored on a scale of 1-5 ponts, that describes the patient's health state. The maximum score of 1 indicates the best health state, higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status with 100 indicating the best health, 0 indicating the worst health status. | 0, 3, 6, 9, 12 months | |
Secondary | Effect of CNA on Quality of Life Parameters Based on SF-36 Questionnaire | SF-36 questionnaire consists of 36 questions that are distributed across eight scales. Each scale is directly transformed into 0-100 scale. The lower the score the more disability, the higher the score the less disability. | 0, 3, 6, 9, 12 months | |
Secondary | Effect of CNA on Fatigue Based on Modified Fatigue Impact Scale (MFIS) | MFIS is a validated, standardized, 21-item questionnaire, which provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. Total scores range from 0-84. The lower the score the less fatigue, the higher the score the more fatigue impairs physical, cognitive, and psychosocial functioning. | 0, 6, 12 months | |
Secondary | Effect of CNA on Depression/Anxiety based on Modified Hospital Anxiety and Depression Scale (HADS-M) | HADS-M is a validated, standardized 16-item questionnaire to evaluate the association between anxiety and depression and the degree of illness acceptance in patients. Total scores range from 0-64. Higher scores indicate a greater degree of anxiety or depression. | 0, 6, 12 months | |
Secondary | Effect of CNA on Sleep Disorders Based on Epworth Sleep Scale (ESS) | The ESS score is a standardized, validated 8-item questionnaire (with scores 0-3 each). The total score can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life. | 0, 6, 12 months | |
Secondary | Effect of CNA on Sleep Disorders Based on Athens Insomnia Scale-8 (AIS-8) | AIS-8 is a standardized, validated questionnaire assessing 8 factors related to nocturnal sleep and daytime dysfunction, which are rated on a 0-3 scale. The sleep is evaluated from the cumulative score of all factors and reported as an individual's sleep outcome. Higher score indicates more sleep disturbances. | 0, 6, 12 months |
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