Cardiac denervation ablation for severe sinus bradycardia
Cardiac Denervation Ablation Strategy for Severe Sinus Bradycardia
This study is testing a new treatment called cardiac denervation ablation for young people with severe sinus bradycardia to see if it can help them avoid getting a pacemaker.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06276816 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the efficacy and safety of cardiac denervation ablation as a treatment for severe sinus bradycardia (SSB). SSB can lead to serious symptoms and complications, and while pacemaker implantation is a common solution, it carries risks and burdens for patients. The study focuses on young patients with elevated vagal tone contributing to their condition, exploring an innovative approach that could reduce the need for pacemakers. The investigators have previously conducted preliminary studies indicating potential benefits of this technique.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with severe sinus bradycardia and related symptoms who are at risk of needing a pacemaker.
Not a fit: Patients with structural heart disease, chronic conditions, or those who have previously undergone certain cardiac procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective treatment for severe sinus bradycardia, potentially eliminating the need for pacemaker implantation.
How similar studies have performed: Preliminary studies have shown promise for cardiac denervation ablation in treating autonomic nervous system-related conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Sinus bradycardia and pacemaker implantation indication: long interval with mean heart rate \<45 bpm or 3s recorded within 6 months before inclusion; 2. Negative atropine test: sinus heart rate\> 90bpm after atropine injection 3. SSB related symptoms: dizziness, palpitations, fatigue, amaurosis, syncope, etc. 4. Age ≥18 and \<60 years old; 5. The patient has agreed to participate in this trial and has signed the informed consent form. Exclusion Criteria: 1. Previous history of atrial arrhythmia ablation or surgical procedure; 2. Structural heart disease, chronic liver and kidney dysfunction, diabetes mellitus, neurological diseases.; 3. Drug-related SSB; 4. presence of left atrial thrombus; 5. Pregnant women.
Where this trial is running
Beijing
- 1Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, China (Recruiting)
Study contacts
- Study coordinator: yan Yao, PhD
- Email: ianyao@263.net.cn
- Phone: 13901121319
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.