Cardiac Denervation Ablation Strategy for Severe Sinus Bradycardia

Sinus Bradycardia Clinical Trial

Official title:

Cardiac Denervation Ablation Strategy for Severe Sinus Bradycardia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06276816
• Other study ID #: 2022-LC14
• Status: Recruiting
• Start date: September 13, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: yan Yao, PhD
• Phone: 13901121319
• Email: ianyao[@]263.net.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bradycardia
• Sick Sinus Syndrome
• Sinus Bradycardia

Locations

Country	Name	City	State
China	1Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

References & Publications (13)

Brignole M, Moya A, de Lange FJ, Deharo JC, Elliott PM, Fanciulli A, Fedorowski A, Furlan R, Kenny RA, Martin A, Probst V, Reed MJ, Rice CP, Sutton R, Ungar A, van Dijk JG; ESC Scientific Document Group. 2018 ESC Guidelines for the diagnosis and managemen — View Citation

Debruyne P, Rossenbacker T, Collienne C, Roosen J, Ector B, Janssens L, Charlier F, Vankelecom B, Dewilde W, Wijns W. Unifocal Right-Sided Ablation Treatment for Neurally Mediated Syncope and Functional Sinus Node Dysfunction Under Computed Tomographic Gu — View Citation

Debruyne P, Rossenbacker T, Janssens L, Collienne C, Ector J, Haemers P, le Polain de Waroux JB, Bazelmans C, Boussy T, Wijns W. Durable Physiological Changes and Decreased Syncope Burden 12 Months After Unifocal Right-Sided Ablation Under Computed Tomogr — View Citation

Hu F, Zheng L, Liang E, Ding L, Wu L, Chen G, Fan X, Yao Y. Right anterior ganglionated plexus: The primary target of cardioneuroablation? Heart Rhythm. 2019 Oct;16(10):1545-1551. doi: 10.1016/j.hrthm.2019.07.018. Epub 2019 Jul 19. — View Citation

Hu F, Zheng L, Liu S, Shen L, Liang E, Ding L, Wu L, Chen G, Fan X, Yao Y. Avoidance of Vagal Response During Circumferential Pulmonary Vein Isolation: Effect of Initiating Isolation From Right Anterior Ganglionated Plexi. Circ Arrhythm Electrophysiol. 20 — View Citation

Hu F, Zheng L, Liu S, Shen L, Liang E, Liu L, Wu L, Ding L, Yao Y. The impacts of the ganglionated plexus ablation sequence on the vagal response, heart rate, and blood pressure during cardioneuroablation. Auton Neurosci. 2021 Jul;233:102812. doi: 10.1016 — View Citation

Qin M, Zhang Y, Liu X, Jiang WF, Wu SH, Po S. Atrial Ganglionated Plexus Modification: A Novel Approach to Treat Symptomatic Sinus Bradycardia. JACC Clin Electrophysiol. 2017 Sep;3(9):950-959. doi: 10.1016/j.jacep.2017.01.022. Epub 2017 Apr 26. — View Citation

Shen WK, Sheldon RS, Benditt DG, Cohen MI, Forman DE, Goldberger ZD, Grubb BP, Hamdan MH, Krahn AD, Link MS, Olshansky B, Raj SR, Sandhu RK, Sorajja D, Sun BC, Yancy CW. 2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope — View Citation

Stavrakis S, Scherlag BJ, Po SS. Autonomic modulation: an emerging paradigm for the treatment of cardiovascular diseases. Circ Arrhythm Electrophysiol. 2012 Apr;5(2):247-8. doi: 10.1161/CIRCEP.112.972307. No abstract available. — View Citation

Sun W, Zheng L, Qiao Y, Shi R, Hou B, Wu L, Guo J, Zhang S, Yao Y. Catheter Ablation as a Treatment for Vasovagal Syncope: Long-Term Outcome of Endocardial Autonomic Modification of the Left Atrium. J Am Heart Assoc. 2016 Jul 8;5(7):e003471. doi: 10.1161/ — View Citation

Tu B, Wu L, Hu F, Fan S, Liu S, Liu L, Ding L, Zheng L, Yao Y. Cardiac deceleration capacity as an indicator for cardioneuroablation in patients with refractory vasovagal syncope. Heart Rhythm. 2022 Apr;19(4):562-569. doi: 10.1016/j.hrthm.2021.12.007. Epu — View Citation

Zhao L, Jiang W, Zhou L, Wang Y, Zhang X, Wu S, Xu K, Liu X. Atrial autonomic denervation for the treatment of long-standing symptomatic sinus bradycardia in non-elderly patients. J Interv Card Electrophysiol. 2015 Aug;43(2):151-9. doi: 10.1007/s10840-015 — View Citation

Zheng L, Sun W, Qiao Y, Hou B, Guo J, Killu A, Yao Y. Symptomatic Premature Ventricular Contractions in Vasovagal Syncope Patients: Autonomic Modulation and Catheter Ablation. Front Physiol. 2021 May 3;12:653225. doi: 10.3389/fphys.2021.653225. eCollectio — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months after ablation procedure
Secondary	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.	12 months after ablation procedure
Secondary	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.	3, 6, 12 months after ablation procedure
Secondary	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.	3, 6, 12 months after ablation procedure
Secondary	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.	3, 6, 12 months after ablation procedure
Secondary	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.	3, 6, 12 months after ablation procedure
Secondary	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.	3, 6, 12 months after ablation procedure