Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04149886
Study type Interventional
Source China National Center for Cardiovascular Diseases
Contact Peng Wang, MD
Phone 861088322407
Email pydiamond@hotmail.com
Status Not yet recruiting
Phase N/A
Start date October 28, 2019
Completion date October 27, 2021

See also
  Status Clinical Trial Phase
Completed NCT00286858 - Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing
Active, not recruiting NCT00228241 - Left Ventricular Function and Remodelling During Permanent Pacing N/A
Completed NCT00180557 - Austria Study - Analysis of Difference Between Active and Passive Fixation Leads Phase 4
Completed NCT01609738 - Left Ventricular Septum Pacing in Patients by Transvenous Approach Through the Inter-ventricular Septum Phase 1/Phase 2
Completed NCT00785564 - Imaging Cardiac Electrical Remodeling With Electrocardiogram Imaging (ECGI)
Recruiting NCT00161551 - Mode Evaluation in Sick Sinus Syndrome Trial (MODEST) Phase 4
Recruiting NCT00224341 - Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation Phase 4
Recruiting NCT05575557 - Pulmonary Artery Pressure and Right Heart Evaluation for Patients Requiring Physiological Pacing Treatment N/A
Recruiting NCT05186220 - Cardioneuroablation Versus Pacemaker Implantation for the Treatment of Symptomatic Sinus Node Dysfunction N/A
Completed NCT03843242 - Evaluation of Ventricular Pacing Suppression Algorithms in Dual Chamber Pacemaker N/A
Terminated NCT00475124 - Virtual Clinic Pacemaker Follow-up Phase 4
Recruiting NCT06288633 - Cardioneuroablation for Bradyarrhythmia N/A
Terminated NCT00236158 - The Danish Multicenter Randomised Study on AAI Versus DDD Pacing in Sick Sinus Syndrome Phase 2/Phase 3
Completed NCT00000561 - Mode Selection Trial in Sinus Node Dysfunction (MOST) Phase 3
Completed NCT02154750 - AV Delay Optimization vs. Intrinsic Conduction in Pacemaker Patients With Long PR Intervals N/A
Completed NCT02198781 - Right Ventricle (RV) Markers of Future Pacing Induced Ventricular Dysfunction - Pilot
Recruiting NCT01477138 - RV Septal Versus Minimized RV Pacing in Sick Sinus Syndrome N/A
Terminated NCT01074749 - Optimal Sensing in Atrial Tachyarrhythmia's Study N/A
Completed NCT00627328 - The Atrial High Rate Episodes in Pacemaker Patients N/A
Completed NCT00161538 - Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation Phase 4