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Clinical Trials/JPRN-jRCTs042200014
JPRN-jRCTs042200014CompletedPhase 4

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

aruse Yoshihisa0 sites70 target enrollmentStarted: June 3, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
70
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The primary endpoint of successful septal placement of the ventricular lead tip as assessed by cardiac CT was significantly higher in the delivery catheter group compared to the stylet group (p=0.024). In the secondary endpoints, the QRS width of pacing was significantly narrower in the delivery catheter group (p=0.003). In lead measurements, impedance at implantation was significantly lower in the delivery catheter group, but there was no significant difference at discharge.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 20age old to ot applicable (—)
Sex
All

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

  • •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

Investigators

Sponsor
aruse Yoshihisa

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