UMIN-ICDS Clinical Trial

Public title

Clinical Outcomes of Left Bundle Branch Area and BachmaNn BunDle Pacing: Multicenter ReAl-World Registry in Kanagawa (LANDMARK study)

Acronym

LANDMARK Study

Scientific Title

Clinical Outcomes of Left Bundle Branch Area and BachmaNn BunDle Pacing: Multicenter ReAl-World Registry in Kanagawa (LANDMARK Study)

Scientific Title:Acronym

LANDMARK Study

Region

Japan

Condition

All patients undergoing pacemaker-related procedures at participating institutions will be included. Pacemaker therapy is defined as transvenous implantation of a conventional pacemaker, an implantable cardiac defibrillator (ICD), or cardiac resynchronization therapy (CRT) device; leadless pacemakers are excluded.

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This multicenter study aims to evaluate the clinical outcomes of left bundle branch area pacing LBBAP and bundle branch pacing BBP in Japan among patients with symptomatic bradycardia and those with heart failure requiring pacing To better reflect real world clinical practice non conduction system pacing non CSP cases including right ventricular septal pacing RVSP as well as atrial pacing sites will also be registered
Accordingly this design will enable
1 assessment of the safety and efficacy of LBBAP through comparison with the non CSP group
2 evaluation of the effectiveness of LBBAP in patients undergoing cardiac resynchronization therapy CRT and
3 analysis of the impact of atrial pacing site on clinical outcomes
Furthermore by conducting a five year follow up after completion of patient enrollment this study is expected to clarify the long term effects of physiological pacing on the preservation of cardiac function and its contribution to clinical outcomes

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The efficacy endpoints will include all-cause mortality, cardiac death, heart failure, and peri-procedural and late complications. The final analysis will be conducted after completion of the 5-year follow-up.

Key secondary outcomes

LBBAP
Evaluation of short and long term outcomes based on baseline patient characteristics and the presence or absence of peri and post procedural complications
Assessment of procedural success rate based on predefined success criteria
Evaluation of the learning curve effect
Impact of institutional operator volume on procedural success rates
Comparative evaluation of hemodynamics and prognosis between LBBP and LVSP
Assessment of lead durability
Evaluation of efficacy in specific cardiomyopathies eg amyloidosis
Assessment of peri procedural complication rates
Evaluation of safety and efficacy in iatrogenic atrioventricular block
Assessment of reduction in the incidence of supraventricular arrhythmias
These outcomes will be compared with the non conduction system pacing non CSP cohort according to the study design
Evaluation of the incidence and prognosis of pacing induced cardiomyopathy at 5 years in CSP versus non CSP cohorts

BBP
Evaluation of clinical outcomes according to atrial pacing site
Assessment of procedural success rate of BBP
Validation of success criteria for BBP
Evaluation of the impact of reactive ATP and atrial pacing site on supraventricular tachyarrhythmias
Assessment of the incidence and persistence of supraventricular arrhythmias according to pacing site

ICD CRT
Evaluation of the efficacy of LOT CRT in Japan
Assessment of the efficacy of ATP delivered via SelectSecure leads in LOT CRTD
Evaluation of efficacy in ischemic vs non ischemic cardiomyopathy and in left bundle branch block vs left ventricular conduction delay
Assessment of the impact of BBP on the incidence of supraventricular arrhythmias in ICD patients
These outcomes will be compared with conventional ICD CRT cohorts according to the study design

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

12

years-old

<=

Age-upper limit

100

years-old

>

Gender

Male and Female

Key inclusion criteria

All patients undergoing pacemaker-related procedures will be included. Pacemaker therapy is defined as transvenous implantation of a conventional pacemaker, an implantable cardiac defibrillator ICD, or cardiac resynchronization therapy CRT device.

Key exclusion criteria

Patients who underwent leadless pacemaker

Target sample size

2000

Name of lead principal investigator

1st name	Yoshihide
Middle name
Last name	Takahashi

Organization

SHIN-YURIGAOKA General Hospital

Division name

Cardiology

Zip code

215-0026

Address

255 Furusawa, Asao-ku, Kawasaki-shi, Kanagawa

TEL

044-322-9991

Email

e2718nm@gmail.com

Name of contact person

1st name	Noriaki
Middle name
Last name	Moriyama

Organization

Shonan Kamakura General Hospital

Division name

Cardiology

Zip code

247-8533

Address

1370-1, Okamoto, Kamakura, Kanagawa

TEL

0467461717

Homepage URL

Email

e2718nm@gmail.com

Institute

LANDMARK study investigators

Institute

Department

Personal name

Organization

Medtronic

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

United States

Co-sponsor

Name of secondary funder(s)

Organization

Shonan Kamakura General Hospital

Address

1370-1, Okamoto, Kamakura, Kanagawa

Tel

0467461717

Email

e2718nm@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

神奈川県

Institutions

Date of disclosure of the study information

2026

Year

06

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2025

Year

10

Month

01

Day

Date of IRB

Anticipated trial start date

2026

Year

06

Month

01

Day

Last follow-up date

2033

Year

05

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This multicenter study aims to evaluate the clinical outcomes of left bundle branch area pacing (LBBAP) and Bachmann bundle pacing (BBP) in Japan among patients with symptomatic bradycardia and heart failure requiring pacing therapy. To better reflect real-world clinical practice, patients undergoing non-conduction system pacing (non-CSP), including right ventricular septal pacing (RVSP), as well as various atrial pacing sites, will also be enrolled.
Accordingly, this study design will enable:
evaluation of the safety and efficacy of LBBAP through comparison with the non-CSP group;
assessment of the efficacy of LBBAP in patients undergoing cardiac resynchronization therapy (CRT); and
evaluation of the impact of atrial pacing sites on clinical outcomes.
In addition, patients will be followed for 5 years after completion of enrollment, which is expected to clarify the long-term effects of physiological pacing on preservation of cardiac function and its contribution to clinical outcomes.

Registered date

2026

Year

04

Month

30

Day

Last modified on

2026

Year

04

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070262