Clinical trial NCT04149886: Cardiac Ganglionated Plexus Ablation Before Permanent Pacemaker Implantation in Patients With Sick Sinus Syndrome
Official title: Cardiac Ganglionated Plexus Ablation Before Permanent Pacemaker Implantation in Patients With Sick Sinus Syndrome - A Multicenter, Randomized, Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardioneuroablation
Permanent Pacemaker Implantation
Sick Sinus Syndrome
Ganglionated Plexus
Keywords: Cardioneuromablation
Ganglionated plexus
Sick Sinus Syndrome
Pacing percentage
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Shanghai Jiaotong University School of Medicine Affiliated Renji Hospital South Campus
name: Heart Center of The First Affiliated Hospital of Xinjiang Medical Unviersity
name: Chinese Academy of Medical Sciences, Fuwai Hospital
First posted: 2019-11-04
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Different studies for cardiac ganglionated plexus（GP） ablation to treat vagal vascular syncope, sinus node dysfunction, and functional atrioventricular block have been published. Investigators have developed a more specific approach of cardiac, called cardioneuroablation . This treatment is based on a high-frequency stimulation (HFS) and/or anatomical landmarks to identify GPs in left atrium，which being targeted by radiofrequency catheter ablation. The feasibility of GPs ablation/cardioneuroablation has already been tested in our center in former studies in humans,with a favorable outcome for the patients involved. The results of the former studies have been submitted for publication. However, there are no prospective randomized studies to evaluate the efficacy and safety of atrial ganglionated plexus ablation for SSS before permanent pacemaker implantation.

The purpose of this study of GAPS in humans is to evaluate the efficacy and safety of cardioneuroablation in patients of sick sinus syndrome before they receive a permanent pacemaker.

Detailed description: This is a multicenter,prospective, open, interventional study. All patients will undergo permanent pacemaker implantation. The study will involve eight different steps, from the screening procedure through study completion: screening, enrollment, pharmacological testing, randomization of group allocation, preprocedural assessment, procedure, follow-up, study completion. The dedicated study members (cardiac electrophysiologists, statisticians) and the PI are responsible for recording all data from the trial on the case report forms (CRFs) and completing the study database. The participants will be randomly allocated in a 1:1 ratio to either GPs ablation followed by permanent pacemaker implantation or pacemaker alone. Randomization will be conducted centrally by an independent statistics department(Oxford Medical Center of National Center for Cardiovascular Diseases, Beijing, China) and stratified by center and age(\<50 or \>=50 years); A dedicated independent physician will be responsible for the safety monitoring. The PI will permit inspection of the trial files and the database by national or international official controlling scientific authorities, if required. The PI will review and monitor completed CRFs and the database at regular intervals throughout the trial.

Eligibility criteria: Inclusion Criteria:

* Sign the informed consent form.
* Diagnosed as SSS, with recurrent symptomatic bradycardia, blackouts, syncope, etc.
* Meet the indications for permanent pacemaker implantation according to the 2018 Chinese pacemaker guidelines (Class I, Class IIa).
* Positive reaction to atropine: The PP interval shortened by more than 20% or the sinus heart rate\>60 bpm after intravenous injection of 2 mg of atropine.

Exclusion Criteria:

* Age \<14 years old or \>75 years old.
* Accompanied with complex congenital heart disease, valvular heart disease, cardiomyopathy and other chronic diseases, such as heart failure (NYHA grade III or IV).
* Acute coronary syndrome or myocardial infarction occurred within 6 months. Cerebrovascular events (such as transient ischemic attack, stroke) or other cerebral blood supply disorders occurred within 3 months.
* History of cardiac surgery and/or permanent cardiac pacemaker implantation.
* TEE or CT found a left atrial thrombus and/or left atrial anteroposterior diameter \> 55mm or LVEF \< 35%.
* Persistent atrial fibrillation, high-degree or complete atrioventricular block; double or triple fascicular block.

Primary outcomes:
measure: Percentage of atrial pacing of permanent pacemaker programming
timeFrame: 12 months （±14 days）
measure: Percentage of pacing of paced rhythm in Holter record
timeFrame: 1 week
Secondary outcomes:
measure: Percentage of sinus rhythm beats in Holter records
timeFrame: 1 week, 3 months(±5 days), 6 months (±7 days)，12 months （±14 days）
measure: Freedom from syncope
timeFrame: 1 week, 3 months(±5 days), 6 months (±7 days)，12 months （±14 days）
measure: Improvement of quality of life: Short Form-36 (SF-36) or Euroqol (EQ-5D)
timeFrame: 1 week, 3 months(±5 days), 6 months (±7 days)，12 months （±14 days）
Other outcomes:
Locations:
city: Beijing
country: China
facility: China National Center for Cardiovascular Diseases
state: Beijing
city: Beijing
country: China
facility: 1Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
References:
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.
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 Guidance. Circ Arrhythm Electrophysiol. 2018 Sep;11(9):e006604. doi: 10.1161/CIRCEP.118.006604.
citation: Cui B, Lu Z, He B, Hu X, Wu B, Xu S, Huang C, Jiang H. Acute effects of ganglionated plexi ablation on sinoatrial nodal and atrioventricular nodal functions. Auton Neurosci. 2011 Apr 26;161(1-2):87-94. doi: 10.1016/j.autneu.2011.01.004.