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

NCT04149886 | Unknown DMC

• 1 other identifier: 20191026
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Cardioneuromablation; Ganglionated plexus; Sick Sinus Syndrome; Pacing percentage

Outcome Measures

Primary Outcomes (2)

• 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）

• 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 Outcomes (3)

• Percentage of sinus rhythm beats in Holter records

  1 week, 3 months(±5 days), 6 months (±7 days)，12 months （±14 days）

• Freedom from syncope

  1 week, 3 months(±5 days), 6 months (±7 days)，12 months （±14 days）

• Improvement of quality of life: Short Form-36 (SF-36) or Euroqol (EQ-5D)

  1 week, 3 months(±5 days), 6 months (±7 days)，12 months （±14 days）

Study Arms (2)

Ablation group(Ablation+pacemaker)

EXPERIMENTAL

The cardioneuroablation will be performed under conscious sedation. After 3-dimensional endocardial surface of the LA and pulmonary veins have been constructed by Ensite system, the GP sites can be located in LA；High frequecy stimulation（HFS）will be used to conform if there is a positive vagal response at each GP site. The upper limits of power and temperature will be set to 30-40 W and 43-60°C, respectively. And if no vagal response been induced during ablation, radiofrequency will be delivered for 30 seconds and stopped in this site. The end point of the ablation procedure will be that no vagal response could be induced by repeat HFS. After ablation of GPs, the participants will receive permanent pacemaker implantation(see arm of control group).

Procedure: cardiac ganglion plexus ablation(cardioneuroablation); Device: Permanent pacemaker implantation

Control group(only pacemaker)

SHAM COMPARATOR

The control group only treated with permanent pacemaker without cardioneuroablation.The participants will receive permanent pacemaker implantation, the pacemaker placement will be done in accordance with standards at each center. All implanted pacemakers are provided two manufacturers (St. Jude Medical or Medtronics), His bundle pacing will be recommended in patients with a LVEF between 35%-45%. After placement of permanent pacemaker, the participants will be followed-up at 1 week, 3,6,12 months. After the permanent pacemaker implantation, the rate response function should be turned off and low pacing rate should be set at 60bpm uniformly in all the eligible participants.

Device: Permanent pacemaker implantation

Interventions

cardiac ganglion plexus ablation(cardioneuroablation) PROCEDURE

Cardiac ganglion plexus ablation in the left atrium will be performed before implanting permanent pacemaker in patients with sick sinus syndrome.

Ablation group(Ablation+pacemaker)

Permanent pacemaker implantation DEVICE

DDD permanent pacemaker will be implanted in the paticipants.

Also known as: St. Jude Medical or Medtronic

Ablation group(Ablation+pacemaker); Control group(only pacemaker)

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• RenJi Hospital: collaborator
• Heart Center of The First Affiliated Hospital of Xinjiang Medical Unviersity: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator

Study Sites (2)

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

Location

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

Beijing, China

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 21316313 BACKGROUND

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

Central Study Contacts

Peng Wang, MD

CONTACT

861088322407; pydiamond@hotmail.com

Yan Yao, MD,PhD

CONTACT

861088322401; ianyao@263.net.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of First Department of Arrythmia Center

Study Record Dates

• First Submitted: October 26, 2019
• First Posted: November 4, 2019
• Study Start: October 28, 2019
• Primary Completion: October 27, 2020
• Study Completion: October 27, 2021
• Last Updated: November 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)