NCT04149886

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-10-28
• Primary completion: 2020-10-27
• Completion: 2021-10-27
• First posted: 2019-11-04
• Last updated: 2019-11-04

Locations

2 sites across 1 country: China