Cardiac Ganglionated Plexus Ablation Before Permanent Pacemaker Implantation in Patients With Sick Sinus Syndrome (GAPS)
Cardioneuroablation, Permanent Pacemaker Implantation, Sick Sinus Syndrome
About this trial
This is an interventional treatment trial for Cardioneuroablation focused on measuring Cardioneuromablation, Ganglionated plexus, Sick Sinus Syndrome, Pacing percentage
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.
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
Experimental
Sham Comparator
Ablation group(Ablation+pacemaker)
Control group(only pacemaker)
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.