Cardiac Denervation Ablation Strategy for Severe Sinus Bradycardia

NCT06276816 | Unknown

• 1 other identifier: 2022-LC14
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sinus Bradycardia

Keywords

Sinus Bradycardia; Cardioneuroablation; Sinus Node Dysfunction; Autonomic Nervous System

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The result of the atropine test

  12 months after ablation procedure

• Changes in quality of life measured by Medical Outcomes Study 36- Item Short Form Health Survey (SF-36)

  3, 6, 12 months after ablation procedure

• Changes in quality of life measured by EuroQol Five Dimensions Questionnaire Visual Analogue Scale (EQ VAS)

  3, 6, 12 months after ablation procedure

• Changes in minmum heart rate

  3, 6, 12 months after ablation procedure

• Changes in mean heart rate

  3, 6, 12 months after ablation procedure

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

SSB patients undergoing cardiac denervation ablation

You may qualify if:

• Negative atropine test: sinus heart rate\> 90bpm after atropine injection
• SSB related symptoms: dizziness, palpitations, fatigue, amaurosis, syncope, etc.
• Age ≥18 and \<60 years old;
• The patient has agreed to participate in this trial and has signed the informed consent form.

You may not qualify if:

• Previous history of atrial arrhythmia ablation or surgical procedure;
• Structural heart disease, chronic liver and kidney dysfunction, diabetes mellitus, neurological diseases.;
• Drug-related SSB;
• presence of left atrial thrombus;
• Pregnant women.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

1Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

RECRUITING

Related Publications (13)

• 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: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. 2017 Aug 1;136(5):e60-e122. doi: 10.1161/CIR.0000000000000499. Epub 2017 Mar 9. No abstract available.

  PMID: 28280231 RESULT

• 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 management of syncope. Eur Heart J. 2018 Jun 1;39(21):1883-1948. doi: 10.1093/eurheartj/ehy037. No abstract available.

  PMID: 29562304 RESULT

• 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/JAHA.116.003471.

  PMID: 27402231 RESULT

• 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.

  PMID: 31330187 RESULT

• 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/j.autneu.2021.102812. Epub 2021 Apr 20.

  PMID: 33940549 RESULT

• 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. 2019 Dec;12(12):e007811. doi: 10.1161/CIRCEP.119.007811. Epub 2019 Nov 25.

  PMID: 31760820 RESULT

• 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. Epub 2021 Dec 9.

  PMID: 34896621 RESULT

• 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. eCollection 2021.

  PMID: 34012407 RESULT

• 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.

  PMID: 22511657 RESULT

• 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/s10840-015-9981-8. Epub 2015 Feb 19.

  PMID: 25693516 RESULT

• 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.

  PMID: 29759719 RESULT

• 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 Guidance. Circ Arrhythm Electrophysiol. 2018 Sep;11(9):e006604. doi: 10.1161/CIRCEP.118.006604.

  PMID: 30354289 RESULT

• 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 Tomographic Guidance in Patients With Neurally Mediated Syncope or Functional Sinus Node Dysfunction. Circ Arrhythm Electrophysiol. 2021 Jun;14(6):e009747. doi: 10.1161/CIRCEP.120.009747. Epub 2021 May 17.

  PMID: 33999698 RESULT

MeSH Terms

Conditions

Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• yan Yao, PhD

  Fuwai Hospital, National Center for Cardiovascular Diseases

  STUDY CHAIR

Central Study Contacts

yan Yao, PhD

CONTACT

13901121319; ianyao@263.net.cn

lihui Zheng, PhD

CONTACT

13910617612; zhenglihui@263.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: February 26, 2024
• Study Start: September 13, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 26, 2024

Record last verified: 2023-11

Locations

CN (1)