An observational study in Sinus Bradycardia, sponsored by China National Center for Cardiovascular Diseases. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-02-26.
Sponsored by China National Center for Cardiovascular Diseases · Observational
This is a prospective clinical observation and registration study. The investigator aimed to evaluate the efficacy and safety of cardiac denervation ablation as a treatment strategy for severe sinus bradycardia.
Severe sinus bradycardia (SSB) is a common clinical condition that can lead to symptoms such as dizziness, fainting, and even cardiac arrest, posing a serious threat to patients' health and life. The causes of SSB vary: in elderly patients, SSB is often caused by ischemia and degenerative changes in the sinoatrial node, while in younger patients, it is often due to abnormal elevation of vagal nerve tone resulting in slowed heart rate and weakened myocardial contractility. Although implanting a pacemaker can effectively alleviate SSB bradycardia, the incidence of pacemaker electrode-related complications (such as electrode displacement, insulation layer rupture, lead infection, and fracture) is not low. Moreover, the impact of pacemaker implantation on patients' quality of life and the economic burden of regular pacemaker battery replacement impose significant psychological and financial burdens on patients, especially young patients. Clearly, for young SSB patients, if the abnormally elevated vagal nerve tone can be continuously reduced, it would be more effective in treating bradycardia and avoiding pacemaker implantation, which has significant social and economic value.
The investigators has pioneered the technique of cardiac denervation ablation, which can modulate the autonomic nervous tone of the heart and is used to treat autonomic nervous system-related diseases. In a preliminary exploratory study involving 6 SSB patients, investigators found that cardiac denervation ablation for SSB can reduce vagal nerve tone, increase sinus heart rate, and effectively alleviate bradycardia symptoms, thus avoiding the need for pacemaker implantation.
Therefore, based on the preliminary work, this project aims to conduct a prospective observational study and establish a registry. SSB patients who meet the indications for pacemaker implantation will be selected to evaluate the efficacy and safety of cardiac denervation ablation for SSB, its impact on quality of life, and the effectiveness of avoiding pacemaker implantation. The project will establish standardized surgical strategies and protocols for cardiac denervation ablation for SSB, summarize experiences, and lay the foundation for the clinical promotion and guideline revision of catheter ablation for SSB.
306 studies on the registry are indexed under Bradycardia; 69 are open to participants now.
This study's planned enrollment of 88 is below the median of 257 across 129 observational studies indexed under Bradycardia.
Browse Bradycardia studies →China National Center for Cardiovascular Diseases is the lead sponsor of 256 studies on the registry; 134 are open to participants now.
Counted across the registry records on this site, refreshed daily.
SSB patients undergoing cardiac denervation ablation
Exclusion Criteria:
Number of patients with postoperative recurrence of bradycardia symptoms
Symptoms such as chest tightness, suffocation, amaurosis, syncope with cardiac arrest with mean heart rate \<45bpm or ≥3s on 12-lead ECG or Holter
Time frame: 12 months after ablation procedure
The result of the atropine test
A negative response was defined as a 25% increase in sinus heart rate or an increase in sinus rhythm to 90 bpm after atropine injection.
Time frame: 12 months after ablation procedure
Changes in quality of life measured by Medical Outcomes Study 36- Item Short Form Health Survey (SF-36)
Patients' quality of life was assessed by Medical Outcomes Study 36- Item Short Form Health Survey (SF-36). The scale contains 36 items in 9 categories of physical functioning, role-physica, bodily pain, general health, vitality, social functioning, role-emotional, mental health and reported health transition. Subjects' scores ranged from 0 to 900, with higher scores representing better quality of life.
Time frame: 3, 6, 12 months after ablation procedure
Changes in quality of life measured by EuroQol Five Dimensions Questionnaire Visual Analogue Scale (EQ VAS)
Patients' quality of life was assessed by EuroQol Five Dimensions Questionnaire Visual Analogue Scale (EQ VAS). Subjects' scores ranged from 0 to 100, with higher scores representing better quality of life.
Time frame: 3, 6, 12 months after ablation procedure
Changes in minmum heart rate
Comparison of postoperative versus baseline minimum heart rate using a 24-hour holter. The device provided to patients prior to discharge or at outpatient visits will be used for this assessment.
Time frame: 3, 6, 12 months after ablation procedure
Changes in mean heart rate
Comparison of postoperative versus baseline mean heart rate using a 24-hour holter. The device provided to patients prior to discharge or at outpatient visits will be used for this assessment.
Time frame: 3, 6, 12 months after ablation procedure
Changes in deceleration capacity
Comparison of postoperative versus baseline deceleration capacity (DC) using a 24-hour holter. Higher DC suggest higher vagal activity. The device provided to patients prior to discharge or at outpatient visits will be used for this assessment.
Time frame: 3, 6, 12 months after ablation procedure
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China National Center for Cardiovascular Diseases