Prospective randomized trial for success rate of left bundle branch pacing comparing anatomical to electrical guided lead placement

JRCT ID: jRCT1070220016

Registered date:18/06/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Bradycardia
• Date of first enrollment: 18/06/2022
• Target sample size: 30
• Study type: Interventional
• Intervention(s): The Methods for Lead Implantation in Achievement of Optimal Left Bundle Branch Area Pacing

Outcome(s)

• Primary Outcome: The primary outcome is success rate of selective LBBAP, which defined Qr or rSR'in V1 and left ventricular activation time (LVAT) < 75ms in V5
• Secondary Outcome: Secondary outcome are procedure time, fluoroscopic time, the dose of contrast agent, pacing threshold and impedance.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Written informed consent has been obtained for participation in this research from the patients or his / her substitute.
(2) Preoperative diagnosis (atrioventricular block, sinus node syndrome, bradycardic atrial fibrillation) is indicated for pacemaker implantation in accordance with the current JHRS guideline.
(3) The age at the time of informed consent is 18 years or older.

Exclude criteria

(1) Cases suspected of being complicated by infectious disease.
(2) The researcher judged that it would be difficult to follow up after one year.
(3) A patient who was eligible for pacing at His bundle, the apex of the right ventricle or right ventricular septum.
(4) A case in which the operator determined that left bundle brunch area pacing (LBBAP) was not appropriate.
(5) A patient who directly selected LBBAP with either electrophysiological or anatomical method.

Related Information

• Primary Sponsor: Tsurugi Takuo