Status:
ACTIVE_NOT_RECRUITING
Pacing Characteristics of a Conventional Bipolar
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborating Sponsors:
Biotronik SE & Co. KG
Conditions:
Symptomatic Bradycardia
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
Study Title: Pacing characteristics of a conventional bipolar, active fixation pacing lead for left bundle branch area pacing in patients with symptomatic bradycardia Study Objectives: To character...
Detailed Description
Patient Enrollment: To target 120 consecutive patients while considering a 20% dropout rate, an approximate sample size of 150 patients is needed. Treatment Plan:This is a prospective, single-arm, op...
Eligibility Criteria
Inclusion
- Adult patients ≥ 20 years of age
- Standard bradycardia pacing indications requiring new ventricular lead implantation
- Able to give informed consent for the participation in the trial
Exclusion
- Patients underwent cardiac resynchronization therapy or implantable cardioverter-defibrillator implantation
- New York Heart Association (NYHA) functional class IV heart failure
- Life expectancy \< 1 year
- Right-sided approach for lead implantation
- Hemodialysis or peritoneal dialysis patients
- Pregnant or breast-feeding women
- Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints
- Participation in another prospective interventional clinical study within a period of 4 weeks prior to the implantation of LBBAP
- Use of any recreational drugs or history of drug addiction
- Any other condition that, in the investigator's judgment, might increase the risk to the patients or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 26 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06011252
Start Date
January 1 2023
End Date
June 26 2026
Last Update
April 17 2025
Active Locations (5)
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1
Chang Gung Memorial Hospital
Linkou District, Taipei, Taiwan, 10507
2
Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
3
China Medical University Hospital
Taichung, Taiwan
4
MacKay Memorial Hospital
Taipei, Taiwan