NCT06011252

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 characterize an approach for left bundle branch area pacing (LBBAP) in patients with bradycardia indications for pacing and to assess implant success rate, safety, and long-term stability with a conventional bipolar, active fixation pacing lead. Methodology: Open-label, prospective, multi-center, non-randomized, single-arm study Study Endpoints: Primary Endpoint:

  • Implant success rate Secondary Endpoints:
  • Intra-operative procedure time and fluoroscopic exposure time
  • Intra-operative intracardiac electrogram (EGM) changes: paced QRS duration, stimulus to left ventricular (LV) activation time, and LBB potential
  • Post-operative imaging data: posteroanterior, left anterior oblique 30O, right anterior oblique 30O, Left lateral views
  • Serial paced 12-lead electrocardiogram (ECG) and intracardiac EGM changes: QRS duration (QRSd), pacing-QRS interval, and new atrial fibrillation (AF)
  • Serial echocardiography changes: left ventricular ejection fraction (LVEF), left atrial (LA) and LV chamber size, and global longitudinal strain (GLS) of tissue Doppler imaging
  • Serial changes of pacing parameters: capture threshold, impedance, and sensing amplitude for both atrial and ventricular Solia S leads
  • Safety: Immediate (\< 24 hours), in-hospital, and chronic (12 months) adverse events

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2026

Expected
Last Updated

May 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

July 28, 2023

Last Update Submit

May 10, 2026

Conditions

Symptomatic Bradycardia

Keywords

FF068Conventional bipolarsymptomatic bradycardialeft bundle branch area pacingLBBAP

Outcome Measures

Primary Outcomes (1)

  • Implant Success Rate

    The purpose of the primary endpoint is to evaluate the overall success rate of the implanted system, including Solia ventricular lead to sense and deliver pacing at 12- month post-implant. Successful sensing performance at 12 months is the demonstrated ability to appropriately sense without intervention for undersensing (i.e., Solia leadrelated adverse event for lead undersensing or loss of sensing) in the period from implant to 12 months, except for normal pulse generator reprogramming. Successful pacing is the demonstrated ability at 12 months to deliver a stimulation pulse with capture, without intervention (i.e., Solia lead-related adverse event for intermittent capture or no lead capture) other than normal pulse generator reprogramming. Success is determined at the subject level.

    Baseline, 12 months

Secondary Outcomes (6)

  • Intra-operative fluoroscopic exposure time

    Baseline, 1 months, 3 months, 6 months ,and 12 months

  • Intra-operative intracardiac electrogram (EGM)

    Baseline, 1 months, 3 months, 6 months ,and 12 months

  • Post-operative imaging data

    baseline

  • Serial paced 12-lead electrocardiogram (ECG) and intracardiac EGM changes

    Screen, Baseline, 1 months, 3 months, 6 months ,and 12 months

  • Serial echocardiography changes

    baseline, 12 months

  • +1 more secondary outcomes

Study Arms (1)

Solia S lead with any BIOTRONIK Pacemaker

OTHER

* Name: Solia S lead with any BIOTRONIK Pacemaker * Model: Solia S45/S53/S60 * Manufacturer: BIOTRONIK SE \& Co. KG * Method of use: LBBAP implantation for all bradycardia indications. * Mechanism of action: (1) Pacemaker stimulates the cardiac tissue to keep stable heart beats in patients with bradycardia. (2) LBBAP can be an alternative to right ventricular (RV) pacing to reduce RV pacing-induced ventricular dyssynchrony. * Device category and grade: E3610 Cardiovascular devices, Class III

Device: Solia S lead with any BIOTRONIK Pacemaker

Interventions

Solia S lead with any BIOTRONIK PacemakerDEVICE

* Name: Solia S lead with any BIOTRONIK Pacemaker * Model: Solia S45/S53/S60 * Manufacturer: BIOTRONIK SE \& Co. KG * Method of use: LBBAP implantation for all bradycardia indications. * Mechanism of action: (1) Pacemaker stimulates the cardiac tissue to keep stable heart beats in patients with bradycardia. (2) LBBAP can be an alternative to right ventricular (RV) pacing to reduce RV pacing-induced ventricular dyssynchrony. * Device category and grade: E3610 Cardiovascular devices, Class III

Solia S lead with any BIOTRONIK Pacemaker

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Chang Gung Memorial Hospital

Linkou District, Taipei, 10507, Taiwan

Location

Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

MacKay Memorial Hospital

Taipei, Taiwan

Location

National Yang Ming Chiao Tung University Hospital

Yilan, Taiwan

Location

Study Officials

  • Chun Chieh Wang

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open-label, prospective, multi-center, non-randomized, single-arm study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2023

First Posted

August 25, 2023

Study Start

January 1, 2023

Primary Completion

March 31, 2025

Study Completion (Estimated)

June 16, 2026

Last Updated

May 13, 2026

Record last verified: 2026-03

Locations

TW(5)