Left Bundle Branch Area Pacing in AVB Patients

Atrioventricular Block Clinical Trial

Official title:

Permanent Left Bundle Branch Area Pacing for Atrioventricular Block

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03851315
• Other study ID #: LBBAP-001
• Status: Recruiting
• Start date: May 1, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: February 2019
• Source: Fu Wai Hospital, Beijing, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrioventricular Block
• Left Bundle Branch Area Pacing

Intervention

Device:
• permanent left bundle branch area pacing
Implant the pacing lead in the left bundle branch area instead of traditional RV pacing site(septal or apical). Successful LBBAP was defined as the paced QRS morphology of right bundle branch block pattern in lead V1 and QRS duration (QRSd) less than 130ms.

Locations

Country	Name	City	State
China	Fu Wai Hospital	BeiJing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Fu Wai Hospital, Beijing, China

Country where clinical trial is conducted

China, 

References & Publications (5)

Chen K, Li Y, Dai Y, Sun Q, Luo B, Li C, Zhang S. Comparison of electrocardiogram characteristics and pacing parameters between left bundle branch pacing and right ventricular pacing in patients receiving pacemaker therapy. Europace. 2018 Nov 20. doi: 10. — View Citation

Guo XG, Liu X, Zhou GB, Sun Q, Yang JD, Luo B, Ouyang F, Ma J, Zhang S. Clinical, electrocardiographic, and electrophysiological characteristics of left upper septal fascicular ventricular tachycardia. Europace. 2018 Apr 1;20(4):673-681. doi: 10.1093/euro — View Citation

Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA. A Novel Pacing Strategy With Low and Stable Output: Pacing the Left Bundle Branch Immediately Beyond the Conduction Block. Can J Cardiol. 2017 Dec;33(12):1736.e1-1736.e3. doi: 10.1016/j.cjca.2017.0 — View Citation

Upadhyay GA, Cherian T, Shatz DY, Beaser AD, Aziz Z, Ozcan C, Broman MT, Nayak H, Tung R. Intracardiac Delineation of Septal Conduction in Left Bundle Branch Block Patterns: Mechanistic Evidence of Left Intra-Hisian Block Circumvented by His Pacing. Circu — View Citation

Vijayaraman P, Naperkowski A, Ellenbogen KA, Dandamudi G. Electrophysiologic Insights Into Site of Atrioventricular Block: Lessons From Permanent His Bundle Pacing. JACC Clin Electrophysiol. 2015 Dec;1(6):571-581. doi: 10.1016/j.jacep.2015.09.012. Epub 2015 Oct 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The synchronization status change at 3 months and 1 year as compared with baseline status.	Left ventricualr strain change from baseline to 3 month, from baselin to 1 year post operation.	3 months and 1 year
Secondary	Pacing threshold change at 3 months and 1 year as compared with baseline status.	The pacing threshold changes between 3-month and baseline status, changes between 1 year and the baseline status.	3 months and 1 year
Secondary	LBBAP related adverse events at 3 months and 1 year as compared with baseline status.	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.	3 months and 1 year
Secondary	left ventricular ejection fraction change at 3 months and 1 year	Left ventricular ejection fraction change from baseline to 3 month, from baselin to 1 year post operation.	3 months and 1 year
Secondary	Right ventricular ejection fraction change at 3 months and 1 year	Right ventricular ejection fraction change from baseline to 3 month, from baselin to 1 year post operation.	3 months and 1 year
Secondary	Left ventricular end systolic diameter change at 3 months and 1 year	Left ventricular end systolic diameter change from baseline to 3 month, from baselin to 1 year post operation.	3 months and 1 year
Secondary	Left ventricular end diastolic diameter change at 3 months and 1 year	Left ventricular end diastolic diameter change from baseline to 3 month, from baselin to 1 year post operation.	3 months and 1 year