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

JRCT ID: jRCTs042200014

Registered date:03/06/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Atrioventricular block
• Date of first enrollment: 16/06/2020
• Target sample size: 70
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Success rate of septal placement at the tip of the ventricular lead evaluated by cardiac CT

Secondary Outcome

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

Key inclusion & exclusion criteria

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

Include 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

Exclude 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

Related Information

• Primary Sponsor: Naruse Yoshihisa
• Secondary Sponsor: Medtronic Japan Co., Ltd.