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

NCT03590353 | Completed FDA Device

• 1 other identifier: xierqdoctorHBP
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Changes of ECG

  time limit of QRS in ms, PR duration in ms, QRS duration and QT duration in ms

  1-12 month after the surgery

• Changes of the Data of Pacemaker

  Threshold value in V, sense in mV of the pacemaker

  1-12 month after the surgery

• Changes of UCG

  UCG:sizs of LA,RA,LV,RV in mm and ejetion fraction of LV and LA (%), and E peak, A peak in mm and velocity time integral (VTI) of LA

  1-12 month after the surgery

Secondary Outcomes (1)

• Rate of Special incidence

  1-12 month after the surgery

Study Arms (2)

Dual chamber pacemaker

ACTIVE COMPARATOR

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;

Device: Dual Chamber Pacemaker

His bundle pacemaker

EXPERIMENTAL

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

Device: His Bundle Pacemaker

Interventions

Dual Chamber Pacemaker 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.

Dual chamber pacemaker

His Bundle Pacemaker 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.

His bundle pacemaker

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Adult Acquired Atrioventricular Block (AVB):
• Third degree or advanced atrioventricular block in any block part with symptomatic bradycardia
• Patients taking other antiarrhythmic drugs in long term, which could result in third degree or advanced AVB (in any block part) and symptomatic bradycardia;
• Patients with carotid sinus hypersensitivity or neurogenic syncope of the heart;

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Hebei Medical University: lead

Study Sites (1)

Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Cardiology in the Second Hospital of Hebei Medical University

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: July 18, 2018
• Study Start: June 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: November 30, 2020
• Last Updated: May 5, 2022

Record last verified: 2021-09

Locations

CN (1)