Clinical trial NCT03851315: Left Bundle Branch Area Pacing in AVB Patients
Official title: Permanent Left Bundle Branch Area Pacing for Atrioventricular Block
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrioventricular Block
Left Bundle Branch Area Pacing
Keywords: Atrioventricular Block
left bundle branch area pacing
Lead sponsor: Fu Wai Hospital, Beijing, China
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive AVB patients with indications for ventricular pacing according to 2013 ESC/EHRA Guidelines. Patients with persistent atrial fibrillation or indications for cardiac resynchronization therapy or implantable cardioverter defibrillator implantation , hypertrophic cardiomyopathy, myocardial amyloidosis, or refused postoperative follow-up were excluded. All patients should sign written informed consent for agreement of the implantation procedure.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The synchronization status change at 3 months and 1 year as compared with baseline status.
timeFrame: 3 months and 1 year
Secondary outcomes:
measure: Pacing threshold change at 3 months and 1 year as compared with baseline status.
timeFrame: 3 months and 1 year
measure: LBBAP related adverse events at 3 months and 1 year as compared with baseline status.
timeFrame: 3 months and 1 year
measure: left ventricular ejection fraction change at 3 months and 1 year
timeFrame: 3 months and 1 year
measure: Right ventricular ejection fraction change at 3 months and 1 year
timeFrame: 3 months and 1 year
measure: Left ventricular end systolic diameter change at 3 months and 1 year
timeFrame: 3 months and 1 year
measure: Left ventricular end diastolic diameter change at 3 months and 1 year
timeFrame: 3 months and 1 year
Other outcomes:
Locations:
city: BeiJing
country: China
facility: Fu Wai Hospital
state: Beijing
Study officials:
References:
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.
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.2017.09.013. Epub 2017 Sep 22.
citation: 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. 2019 Apr 1;21(4):673-680. doi: 10.1093/europace/euy252.
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/europace/euw429.
citation: Upadhyay GA, Cherian T, Shatz DY, Beaser AD, Aziz Z, Ozcan C, Broman MT, Nayak HM, Tung R. Intracardiac Delineation of Septal Conduction in Left Bundle-Branch Block Patterns. Circulation. 2019 Apr 16;139(16):1876-1888. doi: 10.1161/CIRCULATIONAHA.118.038648.
citation: Li X, Zhang J, Qiu C, Wang Z, Li H, Pang K, Yao Y, Liu Z, Xie R, Chen Y, Wu Y, Fan X. Clinical Outcomes in Patients With Left Bundle Branch Area Pacing vs. Right Ventricular Pacing for Atrioventricular Block. Front Cardiovasc Med. 2021 Jul 8;8:685253. doi: 10.3389/fcvm.2021.685253. eCollection 2021.