Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03590353 |
| Other study ID # |
xierqdoctorHBP |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2018 |
| Est. completion date |
November 30, 2020 |
Study information
| Verified date |
September 2021 |
| Source |
The Second Hospital of Hebei Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
