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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

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

NCT ID

NCT04149886

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

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

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

Arm Title

Control group(only pacemaker)

Arm Type

Sham Comparator

Arm Description

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

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

pydiamond@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yan Yao, MD,PhD

Phone

861088322401

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

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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