Left Bundle Branch Area Pacing in AVB Patients

• Conditions: Left Bundle Branch Area Pacing; Atrioventricular Block
• Interventions: Device: permanent left bundle branch area pacing

• Registration Number: NCT03851315
• Lead Sponsor: Fu Wai Hospital, Beijing, China

Brief Summary

Right ventricular pacing (RVP) causes left ventricular mechanical dyssynchrony by inducing electrical interventricular and intraventricular dyssynchrony. His bundle pacing may restore the the atrioventricular, interventricular and intraventricular electrical synchronization, however, Increased pacing threshold might result in the early depletion of the pacemaker, and finally brought on pacemaker replacement, which was one of the major causes of device infection. Pacing the left bundle branch beyond the conduction block site might achieve a low and stable output and narrow QRSd. The investigators were prepared to consecutively include patients with atrioventricular block, divided into the left bundle branch area pacing(LBBAP) group and the conventional right ventricular pacing group. The electrophysiological characteristics of LBBAP and right ventricular pacing were compared with ECG characteristics. The left and right ventricular synchrony and left and right cardiac function were evaluated by 3D ultrasound, and the short-term and long-term safety and efficacy of LBBAP were evaluated.

Detailed Description

This study is intended to be included in Fuwai hospital for admission to the atrioventricular block, with permanent pacemaker implant indications recommended by current guidelines. Patients were assessed for preoperative electrocardiogram, quality of life scores, cardiac function, and left and right ventricular synchrony. Patients were followed up by regular outpatients. The electrocardiogram, quality of life score, echocardiographic function, left and right ventricular synchrony, pacing parameters and pacing ratio were evaluated immediately after surgery, 3 months, 6 months, and 12 months after surgery. At the same time, the left bundle branch area pacing success rate, complications during intraoperative and postoperative follow-up were recorded.

Study Timeline

• Study Start: 2018-05-01
• Status Verified: 2019-02
• Study First Submitted: 2019-02-18
• Study First Submitted QC: 2019-02-20
• Last Update Submitted: 2019-02-20
• Study First Posted: 2019-02-22
• Last Update Posted: 2019-02-22
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Age over 18 years old;
2. Atrioventricular block patients with indication for permanent ventricular pacing;
3. LVEF> 40%;
4. With informed consent signed

Exclusion Criteria

1. Persistent atrial fibrillation;
2. Moderate or more severe valvular disease;
3. Hypertrophic cardiomyopathy；
4. Myocardial amyloidosis；
5. With indication for CRT or ICD implantation according to the current guideline;
6. Poor condition of the acoustic window because of emphysema or other reasons;
7. Patients refused postoperative follow-up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LBBAP group	permanent left bundle branch area pacing	patients received left bundle branch area pacing

Primary Outcome Measures

Name	Time	Method
The synchronization status change at 3 months and 1 year as compared with baseline status.	3 months and 1 year	Left ventricualr strain change from baseline to 3 month, from baselin to 1 year post operation.

Secondary Outcome Measures

Name	Time	Method
Pacing threshold change at 3 months and 1 year as compared with baseline status.	3 months and 1 year	The pacing threshold changes between 3-month and baseline status, changes between 1 year and the baseline status.
LBBAP related adverse events at 3 months and 1 year as compared with baseline status.	3 months and 1 year	The adverse events includes perforation, acute myocardial infarction, loss of capture, increase of pacing threshold, et al. These events were evaluated at baseline, 3 months and 1 year after the procedure, respectively.
left ventricular ejection fraction change at 3 months and 1 year	3 months and 1 year	Left ventricular ejection fraction change from baseline to 3 month, from baselin to 1 year post operation.
Right ventricular ejection fraction change at 3 months and 1 year	3 months and 1 year	Right ventricular ejection fraction change from baseline to 3 month, from baselin to 1 year post operation.
Left ventricular end diastolic diameter change at 3 months and 1 year	3 months and 1 year	Left ventricular end diastolic diameter change from baseline to 3 month, from baselin to 1 year post operation.
Left ventricular end systolic diameter change at 3 months and 1 year	3 months and 1 year	Left ventricular end systolic diameter change from baseline to 3 month, from baselin to 1 year post operation.

Trial Locations

Locations (1)

Fu Wai Hospital; 🇨🇳 BeiJing, Beijing, China