Different Catheter Ablation Strategy in Vasovagal Syncope
NCT05573178 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2023-12-01
Summary
This study is a prospective, single-center randomized controlled clinical trial. patients with refractory vasovagal syncope were randomly divided into two groups according to the proportion of 1:1. Group A: simple left atrial ganglion plexus ablation (RAGP + LSGP + LLGP + LIGP + RIGP ablation); B group: left atrial ganglion plexus combined with right atrial ganglion plexus ablation (group A + consolidation ablation of RAGP at the junction of right atrial septum and superior vena cava). To clarify the role of RAGP in cardiac autonomic nervous system and the effect of ablation, to establish the standard stragtegy of cardiac nerve ablation.
Conditions
- Syncope, Vasovagal
Interventions
- PROCEDURE
-
cardiac ganglion plexus ablation(cardioneuroablation)
Under the guidance of three-dimensional system, the located ganglion plexus was ablated with saline irrigating electrode. The upper limit of power was 40W, the upper limit of temperature was 43 ℃, and the washing rate of saline was 17ml/min. The site of vagal reaction during ablation was defined as the effective ablation site. The surgical end point of denervated interventional therapy is defined as the disappearance of vagal response at the effective ablation site or the ablation of each effective point discharge for at least 30 seconds.
Sponsors & Collaborators
-
China National Center for Cardiovascular Diseases
lead OTHER_GOV
Principal Investigators
-
Yao yan, PhD · Fuwai Hospital, National Center for Cardiovascular Diseases
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-26
- Primary Completion
- 2023-11-20
- Completion
- 2023-11-30
Countries
- China
Study Locations
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