Left Bundle Branch Area Pacing in AVB Patients

NCT03851315 | Unknown DMC FDA Device

• 1 other identifier: LBBAP-001
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrioventricular Block; Left Bundle Branch Area Pacing

Keywords

Atrioventricular Block; left bundle branch area pacing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pacing threshold change at 3 months and 1 year as compared with baseline status.

  3 months and 1 year

• LBBAP related adverse events at 3 months and 1 year as compared with baseline status.

  3 months and 1 year

• left ventricular ejection fraction change at 3 months and 1 year

  3 months and 1 year

• Right ventricular ejection fraction change at 3 months and 1 year

  3 months and 1 year

• Left ventricular end systolic diameter change at 3 months and 1 year

  3 months and 1 year

Study Arms (2)

LBBAP group

patients received left bundle branch area pacing

Device: permanent left bundle branch area pacing

traditional RVP group

Age and sex-matched patients received traditional right ventricular pacing

Interventions

permanent left bundle branch area pacing DEVICE

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.

LBBAP group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age over 18 years old;
• Atrioventricular block patients with indication for permanent ventricular pacing;
• LVEF\> 40%;
• With informed consent signed

You may not qualify if:

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

Sponsors & Collaborators

• Fu Wai Hospital, Beijing, China: lead

Study Sites (1)

Fu Wai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 29759411 BACKGROUND

• 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.

  PMID: 29173611 RESULT

• 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.

  PMID: 30462207 RESULT

• 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.

  PMID: 28160481 RESULT

• 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.

  PMID: 30704273 RESULT

• 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.

  PMID: 34307499 DERIVED

MeSH Terms

Conditions

Atrioventricular Block

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD., PhD., Professor of Medicine, Deputy Director of Arrhythmia Center in Fuwai hospital

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 22, 2019
• Study Start: May 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: February 22, 2019

Record last verified: 2019-02

Locations

CN (1)