Effect of His Bundle Pacing in Treatment of Slow Arrhythmia on Function of Left Atrial and Ventricle
Condition: Slow Arrhythmia; His Bundle Pacing; Function of Left Atrial and Ventricle
MeSH terms: Arrhythmias, Cardiac
Study type: Interventional

Summary: 
      Bradyarrhythmia is one of the common diseases. Also, bradyarrhythmia could result in syncope,
      clinic convulsion, shock, sudden death and so on, which could influence people's life quality
      severely. Artificial pacemaker is the only way that can cure bradyarrhythmia. However,
      traditional right ventricular apical pacing, because its electric stimulation is mostly
      different of the physiological one, could lead to ventricular thick inhomogeneously. At the
      same time, traditional right ventricular apical pacing also could result in cardiac
      arrhythmia and fibrosis, dyssynchrony of the ventricles, which can increase the volume of
      mitral regurgitation. Besides, cardiac resynchronization therapy (CRT), which aims to cure
      chronic heart failure, is also unsatisfactory. On the contrary, the electric stimulation of
      his bundle pacing (HBP) is the same as the physiological one, which produces a relatively
      normal electrical stimulation and synchrony in systolic velocities in ventricular. Thus, HBP
      could produce a better haemodynamic effect, which is the hotspot in pace-making area
      recently.

      The purpose of this study is to conduct a comparison in patients' cardiac function, ECG, and
      pacemakers' threshold value, time limit and so on among dual chamber pacemaker, and HBP.
    

Detailed description: 
      The purpose of this study is to conduct a comparison in patients' cardiac function, ECG, and
      pacemakers' threshold value, time limit and so on among dual chamber pacemaker, and HBP.

      The clinic trial is about to conduct pacemaker implantation in 84 participants, which
      distribute into dual chamber pacemaker, HBP 2 groups in proportion of 1:1 in random. All of
      the participants are supposed to conduct ultrasonic cardiogram (UCG), ECG, BNP and pacemaker
      programing.

      Methods: conduct pacemaker implantation in 84 patients, which distribute into dual chamber
      pacemaker, HBP 2 groups in proportion of 1:1 in random. Patients with The implanting progress
      of dual chamber pacemaker: 1. Conducting venipuncture. Subclavian vein is our first choice.
      Then investigator will set up two venous channels and implant two guiding wires into
      postcava. 2.Putting 2 sheathing canals into heart along with guiding wires. 3.Locating the
      sheathing canals, and putting electrodes into canals. 3.Adjusting the electrodes and
      revolving them anticlockwise to lead them to right atrium and right ventricle respectively
      under the X-ray. 4.Immobilizing electrodes. 5. Some ways to determine whether the electrode
      is fixed or not: the head of the electrodes could beat rhythmically with atrium or ventricle
      or by testing damage current. 6.Removing the canals and suturing.

      The implanting progress of HBP: 1. Conducting venipuncture. Subclavian vein is our first
      choice. Then investigator will set up two venous channels and implant two guiding wires into
      postcava. One of the guide wire is 120cm in length, 0.035 or 0.038 in diameter, which is
      required to lead the C315 sheathing canal. 2.Putting C315 sheathing canal into heart along
      with guiding wires. 3.Locating the C315 sheathing canal, and adjusting the head of C315
      towards ideal pacing location. 3.Implanting the spiral electrodes and fixing them. Leading
      the spiral electrode (type 3830 on Medtronic) to the side of his bundle along the C315 canal
      under the X-ray. The other electrode is leaded to right atrium like dual chamber pacemaker
      under the X-ray. 4.Revolving the 3830 electrode suitably to Immobilizing it in cardiac
      muscle. If the electrode can get the his electric potential and produce his bundle pacing
      successfully, investigator revolve the 3830 electrode and immobilize it. 5. Some ways to
      determine whether the electrode is fixed or not: the head of the electrodes could beat
      rhythmically with atrium or ventricle or by testing damage current. 6.Removing the canals and
      suturing.

      All of the participants are supposed to be tested ECG, UCG and some pacemaker programming on
      pre-operation, 24 hours after operation, 1 month after operation, 3 months after operation, 6
      months after operation, 9 months after operation and 1 year after operation.

      Collection of relevant data:

        1. ECG: testing the amplitude and time limit of QRS, amplitude and dispersion of P wave, PR
           duration, QRS duration and QT duration on the same ECG and cardiac cycle. All the data
           is tested by two cardiologists respectively.

        2. Threshold value, sense and damage current of pacemaker. Two technologists of the
           pacemaker detect the threshold value, sense and damage current of the pacemakers
           respectively. Then all the data will be collected in average value.

        3. UCG: testing the sizes of left atrium (LA), right atrium (RA), left ventricle (LV),
           right ventricle (RV) before and after the operation. Besides, the ejection fraction (EF)
           of LV and LA, and E peak, A peak and velocity time integral (VTI) of LA will be tested
           during the examination. All of the examination will be completed by one cardiologist and
           one physician of cardiac uhrasonography.

        4. the incidence rate of postoperation complication, heart failure, and arrhythmia:
           Cardiologist will contact and ask patients the quality of life by phone or face to face
           in 1 month, 3 months, 6 months, 9 months and 1 year. Meanwhile, patients should complete
           UCG, and BNP testing during the follow-up visit and complete Holter in 6 months.
    

Intervention name(s): Dual Chamber Pacemaker; His Bundle Pacemaker
Intervention type(s): Device; Device
Intervention description(s): 1. Conducting venipuncture. Subclavian vein is our first choice. Then we set up two venous channels and implant two guiding wires into postcava. 2.Putting 2 sheathing canals into heart along with guiding wires. 3.Locating the sheathing canals, and putting electrodes into canals. 3.Adjusting the electrodes and revolving them anticlockwise to lead them to right atrium and right ventricle respectively under the X-ray. 4.Immobilizing electrodes. 5. Some ways to determine whether the electrode is fixed or not: the head of the electrodes could beat rhythmically with atrium or ventricle or by testing damage current. 6.Removing the canals and suturing.; 1.Conducting venipuncture. Subclavian vein is our first choice. Then we set up two venous channels and implant two guiding wires into postcava. One of the guide wire is 120cm in length, 0.035 or 0.038 in diameter, which is required to lead the C315 sheathing canal. 2.Putting C315 sheathing canal into heart along with guiding wires. 3.Locating the C315 sheathing canal, and adjusting the head of C315 towards ideal pacing location. 3.Implanting the spiral electrodes and fixing them. Leading the spiral electrode to the side of his bundle along the C315 canal under the X-ray. The other electrode is leaded to right atrium like dual chamber pacemaker under the X-ray. 4.Revolving the 3830 electrode suitably to Immobilizing it in cardiac muscle. If the electrode can get his electric potential and produce his bundle pacing successfully, we revolve the 3830 electrode and immobilize it.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment