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Examination of the usefulness of right ventricular septal pacing using a delivery catheter

Examination of the usefulness of right ventricular septal pacing using a delivery catheter -Mt FUJI (Comparison of delivery catheter- and stylet- based RV lead placement at RV septum under fluoroscopic guidance judged by cardiac computed tomography) trial-

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042200014
Enrollment
70
Registered
2020-06-03
Start date
2020-06-16
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

Atrioventricular block

Interventions

To evaluate the position of the tip of the ventricular lead using a delivery catheter type lead or stylet type lead in patients scheduled to undergo pacemaker implantation. Assignment is randomized.

Sponsors

Naruse Yoshihisa
Lead Sponsor
Medtronic Japan Co., Ltd.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients over 20 years old 2. Patients diagnosed with atrioventricular block and scheduled to undergo pacemaker implantation for therapeutic purposes 3. Patients who can obtain written consent for participation in this study

Exclusion criteria

Exclusion criteria: 1. Patients with severely reduced cardiac function (left ventricular ejection fraction [LVEF] <35%) 2. Patients with chronic renal failure who regularly perform hemodialysis 3. Patients with a history of heart surgery 4. Patients with chronic atrial fibrillation 5. Patients with congenital heart disease 6. Patients who are judged to be inappropriate for enrollment in this study by the investigator or investigator

Design outcomes

Primary

MeasureTime frame
Success rate of septal placement at the tip of the ventricular lead evaluated by cardiac CT

Secondary

MeasureTime frame
Pacing QRS width Surgery time Perspective time Ventricular lead screw-in times Crest value, threshold value, impedance of ventricular lead at implantation and discharge The incidence of abnormal ventricular lead position at discharge

Contacts

Public ContactYoshihisa Naruse

Hamamatsu University School of Medicine

ynaruse@hama-med.ac.jp+81-53-435-2356

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026