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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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Page 1 of 2 (5 locations)

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