NOVEL II

Efficacy and safety of left bundle branch area pacing with stylet-driven extendable screw-in lead: A Multicenter Randomized Controlled Trial (NOVEL II stud

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009208

Enrollment

200

Registered

2024-02-27

Start date

2024-01-16

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

None listed

Interventions

Medical Device, Procedure/Surgery : This study is a prospective, randomized, multicenter, public, superiority assessment, and researcher-led clinical study. After screening in patients requiring perma

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who are 19 years of age or older and have agreed to the study (if voluntary consent is deemed difficult, the consent of the legal representative shall be obtained together) 2. Patients requiring permanent pacemaker insertion due to the following reasons - 3 degree atrioventricular block - Patients expected to have ventricular heartbeat of 40% or more due to ventricular blockages of 1 or 2 degrees

Exclusion criteria

Exclusion criteria: 1. Patients who have had a past pacemaker or defibrillator inserted 2. Patients with left ventricular ejection fraction (LVEF) of 50% or less 3. a patient with an indication of scrupulous infusion 4. Patients with a life expectancy of less than one year. (e.g., patients who can't even have a heart transplant,), patients undergoing DNR, patients in hospice wards for refusing life-sustaining treatment, end-stage cancer patients who are unable to receive radiation or chemotherapy, etc.)

Design outcomes

Primary

Measure	Time frame
Left ventricular ejection fraction at 12 months of procedure (LVEF)	—

Secondary

Measure	Time frame
Side effects related to the procedure;heart death;hospitalization due to heart failure;Echocardiographic findings (ventricular septal thickness, end-systolic left ventricular volume, end-systolic left ventricular Volume, diastolic function index, left atrial diameter, left atrial volume index, mitral valve, tricuspid valve degree of reflux, right ventricular contractile force, right ventricular contractile pressure);ECG results (QRS area and shape, QT interval, degree of T-wave fluctuation, LVAT, V6-V1 interpeak interval);Blood test results (NTproBNP);Procedural indicators (success or failure, procedure time, radiation time, LV activation time, V6-V1 peak to peak interval);Pacemaker Indicator (success or failure, procedure time, radiation time, LV activation time, V6-V1 peak to peak interval)	—

Measure

Time frame

Side effects related to the procedure;heart death;hospitalization due to heart failure;Echocardiographic findings (ventricular septal thickness, end-systolic left ventricular volume, end-systolic left ventricular Volume, diastolic function index, left atrial diameter, left atrial volume index, mitral valve, tricuspid valve degree of reflux, right ventricular contractile force, right ventricular contractile pressure);ECG results (QRS area and shape, QT interval, degree of T-wave fluctuation, LVAT, V6-V1 interpeak interval);Blood test results (NTproBNP);Procedural indicators (success or failure, procedure time, radiation time, LV activation time, V6-V1 peak to peak interval);Pacemaker Indicator (success or failure, procedure time, radiation time, LV activation time, V6-V1 peak to peak interval)

—

Countries

Korea, Republic of

Contacts

Public ContactYong YeongHun

Samsung Medical Center

crong1996@outlook.kr+82-2-2148-7610

Outcome results