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

Primary Purpose

Cardioneuroablation, Permanent Pacemaker Implantation, Sick Sinus Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cardiac ganglion plexus ablation(cardioneuroablation)
Permanent pacemaker implantation
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardioneuroablation focused on measuring Cardioneuromablation, Ganglionated plexus, Sick Sinus Syndrome, Pacing percentage

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ablation group(Ablation+pacemaker)

Control group(only pacemaker)

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.
Percentage of pacing of paced rhythm in Holter record
Percentage of pacing of paced rhythm in Holter record 1week after pacemaker implantation

Secondary Outcome Measures

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.
Freedom from syncope
Freedom from sycope at 1 week, 3 months, 6 months and 12 months with outpatient clinic follow up.
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.

Full Information

First Posted
October 26, 2019
Last Updated
October 31, 2019
Sponsor
China National Center for Cardiovascular Diseases
Collaborators
Shanghai Jiaotong University School of Medicine Affiliated Renji Hospital South Campus, Heart Center of The First Affiliated Hospital of Xinjiang Medical Unviersity, Chinese Academy of Medical Sciences, Fuwai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04149886
Brief Title
Cardiac Ganglionated Plexus Ablation Before Permanent Pacemaker Implantation in Patients With Sick Sinus Syndrome
Acronym
GAPS
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 28, 2019 (Anticipated)
Primary Completion Date
October 27, 2020 (Anticipated)
Study Completion Date
October 27, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China National Center for Cardiovascular Diseases
Collaborators
Shanghai Jiaotong University School of Medicine Affiliated Renji Hospital South Campus, Heart Center of The First Affiliated Hospital of Xinjiang Medical Unviersity, Chinese Academy of Medical Sciences, Fuwai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardioneuroablation, Permanent Pacemaker Implantation, Sick Sinus Syndrome, Ganglionated Plexus
Keywords
Cardioneuromablation, Ganglionated plexus, Sick Sinus Syndrome, Pacing percentage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ablation group(Ablation+pacemaker)
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group(only pacemaker)
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
cardiac ganglion plexus ablation(cardioneuroablation)
Intervention Description
Cardiac ganglion plexus ablation in the left atrium will be performed before implanting permanent pacemaker in patients with sick sinus syndrome.
Intervention Type
Device
Intervention Name(s)
Permanent pacemaker implantation
Other Intervention Name(s)
St. Jude Medical or Medtronic
Intervention Description
DDD permanent pacemaker will be implanted in the paticipants.
Primary Outcome Measure Information:
Title
Percentage of atrial pacing of permanent pacemaker programming
Description
Percentage of atrial pacing of permanent pacemaker at 12 months after the implantation of permanent pacemaker with program control.
Time Frame
12 months (±14 days)
Title
Percentage of pacing of paced rhythm in Holter record
Description
Percentage of pacing of paced rhythm in Holter record 1week after pacemaker implantation
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Percentage of sinus rhythm beats in Holter records
Description
Percentage of sinus rhythm beats at 1 week, 3 months, 6 months and 12 months with Holter.
Time Frame
1 week, 3 months(±5 days), 6 months (±7 days),12 months (±14 days)
Title
Freedom from syncope
Description
Freedom from sycope at 1 week, 3 months, 6 months and 12 months with outpatient clinic follow up.
Time Frame
1 week, 3 months(±5 days), 6 months (±7 days),12 months (±14 days)
Title
Improvement of quality of life: Short Form-36 (SF-36) or Euroqol (EQ-5D)
Description
Improvement of quality of life with questionair at 1 week, 3 months, 6 months and 12 months with outpatient clinic follow up.
Time Frame
1 week, 3 months(±5 days), 6 months (±7 days),12 months (±14 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Wang, MD
Phone
861088322407
Email
pydiamond@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Yao, MD,PhD
Phone
861088322401
Email
ianyao@263.net.cn
Facility Information:
Facility Name
China National Center for Cardiovascular Diseases
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Facility Name
1Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29759719
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.
Results Reference
background
PubMed Identifier
30354289
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.
Results Reference
background
PubMed Identifier
21316313
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.
Results Reference
background

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

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