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Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia

2021年8月19日 更新者:Xu Liu、Shanghai Chest Hospital

A Multicenter Randomized Controlled Study of Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia

This is a multicenter randomized controlled study. By comparing patients with sinus bradycardia undergoing cardiac autonomic ganglion ablation and pacemaker therapy, and long-term follow-up to evaluate its safety and effectiveness after surgery, in order to evaluate the safety and effectiveness of cardiac autonomic ganglion ablation in the treatment of sinus bradycardia.

研究概览

研究类型

介入性

注册 (预期的)

240

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Aged 18 to 80 years old;
  2. Symptomatic sinus bradycardia;
  3. Not meet the class I indications for pacemaker implantation.

Exclusion Criteria:

  1. Structural heart disease, heart surgery history;
  2. Drug-induced SB, sinus pause >2.0 s, positive atropine test, corrected sinus node recovery time (cSNRT) >525 ms;
  3. Any atrial or ventricular arrhythmia, or a history of ablation procedures to treat atrial tachyarrhythmias;
  4. With Significant congenital heart disease, ejection fraction was <40% measured by echocardiography;
  5. Allergic to contrast media;
  6. Contraindication to anticoagulation medications;
  7. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);

9. Poor general health; 10.Life expectancy less than 6 months.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Cardiac autonomic nerve modification
Patients with sinus bradycardia undergoing cardiac autonomic ganglion ablation. Specific anatomic ablation of the 4 major left atrial GP and aorta-superior vena cava (Ao-SVC) GP was performed. Briefly, catheter ablation was performed under the guidance of an electroanatomic mapping system (CARTO,BiosenseWebster,DiamondBar,California). After completed the electroanatomic mapping of the left atrium was complete and pulmonary vein (PV) ostia identified, presumed GP clusters were ablated 1 to 2cm outside the PV-left atrium junctions at the following sites: the left superolateral area (leftsuperior GP[LSGP]), the leftinfer oposterior area(left inferior GP[LIGP]), the right superoanterior area (rightanterior GP[RAGP]), the right inferoposterior area(right inferior GP[RIGP]), and the Ao-SVC fat pad (Ao-SVCGP), and in that sequence.
有源比较器:Pacemaker
Patients with sinus bradycardia received pacemaker implantation. The patient lay flat on the bed, puncture the subclavian vein and insert two guide wires. Cut the skin under the guide wire to make a skin bag, and stop bleeding accurately to avoid continuous bleeding of the skin bag. The pacemaker electrode is inserted into the heart cavity by guiding the guide wire, one is placed in the ventricle and the other in the atrium, and the corresponding parameters of the electrode, such as pacing threshold, impedance, etc., are measured at the same time. If the parameters are good, fix the electrode, connect the electrode with the pacemaker, place the pacemaker in the skin bag, fix the pacemaker and electrode, suture the skin layer by layer, and the operation is completed.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Symptom score after operation
大体时间:48 months
Each patient subjectively assessed his or her SB-related symptom, including dizziness, fatigue, and palpitation, on a score of 1 to 10 points (mildtosevere). The total SB-related symptom score for each patient was calculated as the sum of all scores for individual symptoms.
48 months

次要结果测量

结果测量
措施说明
大体时间
Quality of life score
大体时间:48 months
The Medical Outcomes Study Short-Form 36 Health Survey (SF-36) was used to assess quality of life (QoL) at baseline and 12 months after ablation. The self-administration mode was strictly followed for QoL surveys. TheSF-36 assesses 8 specific QoL domains, namely physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problem, and mental health. For each subscale, scores were transformed to a scale ranging from 0 to 100, with lower scores representing a lower QoL.
48 months
Psychological quality score
大体时间:48 months

The Zung Self-Rating Depression Scale is a short self administered survey to quantify the depressed status of a patient. There are 20 items on the scale that rate the four common characteristics of depression: the pervasive effect, the physiological equivalents, other disturbances, and psychomotor activities.

There are ten positively worded and ten negatively worded questions. Each question is scored on a scale of 1-4 (a little of the time, some of the time, good part of the time, most of the time).

48 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2021年9月1日

初级完成 (预期的)

2026年8月31日

研究完成 (预期的)

2026年8月31日

研究注册日期

首次提交

2021年8月15日

首先提交符合 QC 标准的

2021年8月19日

首次发布 (实际的)

2021年8月25日

研究记录更新

最后更新发布 (实际的)

2021年8月25日

上次提交的符合 QC 标准的更新

2021年8月19日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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