Cardiac Ganglionated Plexus Ablation Before Permanent Pacemaker Implantation in Patients With Sick Sinus Syndrome

Sick Sinus Syndrome Clinical Trial

— GAPS  

Official title:

Cardiac Ganglionated Plexus Ablation Before Permanent Pacemaker Implantation in Patients With Sick Sinus Syndrome - A Multicenter, Randomized, Prospective Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04149886
• Other study ID #: 20191026
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 28, 2019
• Est. completion date: October 27, 2021

Study information

• Verified date: October 2019
• Source: China National Center for Cardiovascular Diseases
• Contact: Peng Wang, MD
• Phone: 861088322407
• Email: pydiamond[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 27, 2021
• Est. primary completion date: October 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardioneuroablation
• Ganglionated Plexus
• Permanent Pacemaker Implantation
• Sick Sinus Syndrome
• Syndrome

Intervention

Procedure:
• cardiac ganglion plexus ablation(cardioneuroablation)
Cardiac ganglion plexus ablation in the left atrium will be performed before implanting permanent pacemaker in patients with sick sinus syndrome.

Device:
• Permanent pacemaker implantation
DDD permanent pacemaker will be implanted in the paticipants.

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases	Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen, Heart Center of The First Affiliated Hospital of Xinjiang Medical Unviersity, Shanghai Jiaotong University School of Medicine Affiliated Renji Hospital South Campus

Country where clinical trial is conducted

China, 

References & Publications (3)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of atrial pacing of permanent pacemaker programming	Percentage of atrial pacing of permanent pacemaker at 12 months after the implantation of permanent pacemaker with program control.	12 months (±14 days)
Primary	Percentage of pacing of paced rhythm in Holter record	Percentage of pacing of paced rhythm in Holter record 1week after pacemaker implantation	1 week
Secondary	Percentage of sinus rhythm beats in Holter records	Percentage of sinus rhythm beats at 1 week, 3 months, 6 months and 12 months with Holter.	1 week, 3 months(±5 days), 6 months (±7 days),12 months (±14 days)
Secondary	Freedom from syncope	Freedom from sycope at 1 week, 3 months, 6 months and 12 months with outpatient clinic follow up.	1 week, 3 months(±5 days), 6 months (±7 days),12 months (±14 days)
Secondary	Improvement of quality of life: Short Form-36 (SF-36) or Euroqol (EQ-5D)	Improvement of quality of life with questionair at 1 week, 3 months, 6 months and 12 months with outpatient clinic follow up.	1 week, 3 months(±5 days), 6 months (±7 days),12 months (±14 days)