Effect of His Bundle Pacing in Treatment of Slow Arrhythmia on Function of Left Atrial and Ventricle

NCT ID: NCT03590353

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2020-11-30

Brief 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.

Conditions

Slow Arrhythmia; His Bundle Pacing; Function of Left Atrial and Ventricle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dual chamber pacemaker

1. Patients with sinus node disfunction: sinus node disfunction with obvious clinical symptoms, including sinus pause; patients with chronotropismus disfunction; patients have to take some medicine due to some diseases, but the medicine may result to sinus bradycardia.

2. Adult Acquired Atrioventricular Block (AVB): (1). Third degree or advanced atrioventricular block in any block part with symptomatic bradycardia (2). Patients taking other antiarrhythmic drugs in long term, which could result in third degree or advanced AVB (in any block part) and symptomatic bradycardia;

3. Patients with acute myocardial infarction (AMI) and AVB:

(1). Patients with His-Purkinje system persistent second degree AVB and retardant or third degree AVB after STEMI; (2). Patients with temporary severe second degree AVB or third degree AVB (block part under atrioventricular node) and retardant; 4. Patients with carotid sinus hypersensitivity or neurogenic syncope of the heart;

Group Type: ACTIVE_COMPARATOR

Dual Chamber Pacemaker

Intervention Type: DEVICE

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.

His bundle pacemaker

His Bundle Pacemaker: All of the Criteria Inclusion of dual chamber pacemaker excluding patients with block part under the his bundle;

Group Type: EXPERIMENTAL

His Bundle Pacemaker

Intervention Type: DEVICE

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.

Interventions

Dual Chamber Pacemaker

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.

Intervention Type: DEVICE

His Bundle Pacemaker

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients with sinus node disfunction: sinus node disfunction with obvious clinical symptoms, including sinus pause; patients with chronotropismus disfunction; patients have to take some medicine due to some diseases, but the medicine may result to sinus bradycardia.

2. Adult Acquired Atrioventricular Block (AVB):

2.1.Third degree or advanced atrioventricular block in any block part with symptomatic bradycardia

2.2.Patients taking other antiarrhythmic drugs in long term, which could result in third degree or advanced AVB (in any block part) and symptomatic bradycardia;

2.3.Patients with carotid sinus hypersensitivity or neurogenic syncope of the heart;

Exclusion Criteria

1.Patients with congenital heart diseases,such as arial septal defect,ventricuar defect, rheumatic heart diseases, and valvular heart diseases,such as MS, MI, TS, TI.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ruiqin xie

Director of the Department of Cardiology in the Second Hospital of Hebei Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

xierqdoctorHBP

Identifier Type: -

Identifier Source: org_study_id