臨床研究等提出・公開システム

Date of registration	June. 18, 2022
Last modified on	June. 18, 2022
Trial ID	jRCT1070220016

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

Contact for Scientific Queries	Name	Tsurugi Takuo
	Affiliation	Saiseikai Kumamoto Hospita
	Address	5-3-1 Chikami Minami-ku Kumamoto city Kumamoto
	Telephone	+81-96-351-8000
	E-mail	takuo-tsurugi@saiseikaikumamoto.jp
Contact for Public Queries	Name	Tsurugi Takuo
	Affiliation	Saiseikai Kumamoto Hospita
	Address	5-3-1 Chikami Minami-ku Kumamoto city Kumamoto
	Telephone	+81-96-351-8000
	E-mail	takuo-tsurugi@saiseikaikumamoto.jp

Recruitment status	Pending

Anticipated date of first enrollment		June. 18, 2022
Target sample size		30
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion 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.
	Exclusion 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.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Bradycardia
Intervention(s)		The Methods for Lead Implantation in Achievement of Optimal Left Bundle Branch Area Pacing
Primary Outcome(s)		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(s)		Secondary outcome are procedure time, fluoroscopic time, the dose of contrast agent, pacing threshold and impedance.

Primary Sponsor	President and Chief Executive Officer Koichi Nakao

Name of Certified Review Board	Saiseikai Kumamoto Hospital Ethics Committee
Address	5-3-1 Chikami Minami-ku Kumamoto city Kumamoto, Kumamoto
Telephone	+81-96-351-8000
E-Mail	rks@saiseikaikumamoto.jp
Approval Status	Approval
Date of approval	May. 30, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none