LUMIERE

Lumenless lead utilizing atrial septal pacing in patients with cardiac implantable electric device as a more accurate technology - LUMIERE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1042250050

Enrollment

300

Registered

2025-06-20

Start date

2025-07-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac arrhythmias and/or heart failure

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients are indicated for de novo Medtronic cardiac implantable electronic device (CIED) implantation Patients who are able to obtain written consent and/or consent from the patient or legal representative, subject to institutional and local requirements Patients scheduled for atrial lead implantation in the atrial septum using the SelectSecure lead

Exclusion criteria

Exclusion criteria: Patients with permanent atrial fibrillation. Patients under 18 years of age Patients with life expectancy < 1 year Patients with atrial arrest. Patients with a history of device implantation Subjects participating in a clinical trial of an investigational drug or device, which may introduce bias or interference to the endpoints and follow-up of the study. Pregnant subjects (do not exclude if permitted by regulatory requirements in the country/region where you are performing; perform a pregnancy test if necessary).

Design outcomes

Primary

Measure	Time frame
The primary objective is to estimate the probability of implant success of a patient who undergoes an implant with atrial SelectSecure Model 3830 lead and its delivery catheters without atrial SelectSecure lead related complications (causal relationship) through 1 month (30-day) post index procedure. The primary objective is a composite safety and effectiveness endpoint at 1-month post index procedure. Primary Effectiveness Endpoint: - Confirmation from the physician that the SelectSecure lead could be placed in the atrial septum based on fluoroscopic judgment. - No system modification (e.g., lead explant, lead replacement or lead repositioning) of the atrial SelectSecure lead between implant and hospital discharge. Primary Safety Endpoint: Freedom from atrial SelectSecure lead related (causal Relationship) complications at 1-month (i.e., 30 days) post index procedure.	—

Measure

Time frame

The primary objective is to estimate the probability of implant success of a patient who undergoes an implant with atrial SelectSecure Model 3830 lead and its delivery catheters without atrial SelectSecure lead related complications (causal relationship) through 1 month (30-day) post index procedure. The primary objective is a composite safety and effectiveness endpoint at 1-month post index procedure. Primary Effectiveness Endpoint: - Confirmation from the physician that the SelectSecure lead could be placed in the atrial septum based on fluoroscopic judgment. - No system modification (e.g., lead explant, lead replacement or lead repositioning) of the atrial SelectSecure lead between implant and hospital discharge. Primary Safety Endpoint: Freedom from atrial SelectSecure lead related (causal Relationship) complications at 1-month (i.e., 30 days) post index procedure.

—

Secondary

Measure	Time frame
Characterize atrial SelectSecure lead related (causal relationship) complication rate at 24 months post implant in subjects undergoing an atrial SelectSecure implant	—

Contacts

Public ContactEiichiro Goto

Medtronic Japan

goto.eiichiro@medtronic.com+81-80-4441-9938

Outcome results