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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-

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

70

There were 70 subjects in the study. The mean age was 78+-11 years (31-97 years). There were 30 males and 40 females. Atrioventricular block was classified as grade I in 0 patients, Wenckebach in 0 patients, Mobitz in 2 patients, severe in 21 patients, and grade III in 47 patients. Left ventricular ejection fraction measured by echocardiography was 64;+-8% on average. Ventricular lead implantation was performed as per allocation in all patients, and no crossover was observed. There was no bias in comorbidities or laboratory findings between the two groups, and background factors were well adjusted by random assignment.

The registration status was good and was completed earlier than the planned registration period. The number of patients enrolled per institution was 17-20% at Juntendo University Shizuoka Hospital, Chutoen General Medical Center, and Shizuoka Medical Center, and 10% at other institutions. A total of 70 patients were enrolled in the study, and 69 patients completed the study; one patient was discontinued by lead dislodgment and withdrew consent.

The total number of events was 3 (including 3 serious diseases). In the stylet group, there were 2 cases of lead dislodgment and 1 case of wound complication. In the delivery catheter group, there was one case of Takotsubo cardiomyopathy.

(Primary endpoint) Successful septal placement of ventricular lead tip as assessed by cardiac CT (percentage and actual number) Delivery catheter group 78% (28/36) vs. stylet group 50% (17/34) p=0.024 (Secondary endpoints) QRS width of pacing (and incremental QRS width of pacing compared with pre-implantation QRS width) (mean +- standard deviation) QRS width of pacing (and incremental QRS width of pacing compared to pre-implantation QRS width) (mean +- standard deviation) Delivery catheter group 129 +- 20 ms vs. stylet group 142 +- 15 ms p=0.003 Surgical time (median and quartiles) Delivery catheter group 91 (68-119) min vs. stylet group 85 (59-118) min; p=0.488 Fluoroscopy time (median and quartile) Median and quadrant fluoroscopy time (delivery catheter group 18 (12-24) min vs. stylet group 13 (10-22) min; p=0.129) Ventricular lead screw-in frequency (median and quartiles) Median and quartile ventricular lead screw-in frequency (delivery catheter group 1 (1-2) vs. 1 (1-2) in the stylet group; p=0.749) Ventricular lead height, threshold, and impedance at implantation and discharge (mean +- standard deviation) <At implantation Wave height: delivery catheter group 10.9+-4.3 mV vs. stylet group 9.3+-4.7 mV; p=0.176 Threshold: 0.68+-0.31 V for delivery catheter vs. 0.64+-0.23 V for stylet; p=0.608 Impedance: Delivery group 690+-97ohm vs. Stylet group 622+-130ohm p=0.016 <At discharge Wave height: delivery catheter group 13.8+-4.8 mV vs. stylet group 11.5+-4.8 mV; p=0.079 Threshold: 0.72+-0.32 V for delivery catheter vs. 0.75+-0.23 V for stylet; p=0.703 Impedance: delivery catheter group 567+-69ohm vs. stylet group 568+-106ohm p=0.943 Incidence of abnormal ventricular lead position at hospital discharge (percentage and actual number) Delivery catheter group 0% (0/36) vs. stylet group 3% (1/34) p=0.486

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.

Mar. 31, 2023

No

No

https://jrct.niph.go.jp/latest-detail/jRCTs042200014

Naruse Yoshihisa

Hamamatsu University School of Medicine

1-20-1,Handayama,Higashi-ku,Hamamatsu city,Shizuoka

ynaruse@hama-med.ac.jp

Naruse Yoshihisa

Hamamatsu University School of Medicine

1-20-1,Handayama,Higashi-ku,Hamamatsu city,Shizuoka

+81-53-435-2356

ynaruse@hama-med.ac.jp

Complete

June. 03, 2020

Interventional

randomized controlled trial

single blind

active control

parallel assignment

treatment purpose

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

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

Both

Atrioventricular block

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.

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

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

+81-53-435-2680

April. 17, 2020

none