Study on Effectiveness and Safety of LBBaP With Solia S and Selectra 3D Developed by BIOTRONIK

NCT05793502 | Recruiting DMC FDA Device

• 1 other identifier: 20230320
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aimed to assess the effectiveness and safety of LBBaP with Solia S and Selectra 3D in the Chinese population by analyzing the operation success rate and the system stability during follow-up visits.

Conditions

Consented to Participate in the Trial and Signed an ICF; Patients With an Indication for PM Implantation or CRTP

Outcome Measures

Primary Outcomes (3)

• Implantation success rate of LBBaP

  Implantation success rate of LBBaP

  During the surgery

• Intraoperatively, the incidence of serious adverse events for devices associated with Solia S and Selectra 3D implantation rate

  Intraoperatively, the incidence of serious adverse events for devices associated with Solia S and Selectra 3D implantation rate

  During the surgery

• Occurrence of serious adverse events rate

  The incidence of serious adverse events associated with permanent pacemaker implantation or cardiac resynchronization from the time of surgery to the 12-month post-implantation visit Incidence of serious adverse events associated with the treatment procedure

  From the time of surgery to the 12-month post-implantation visit

Secondary Outcomes (4)

• Number of participants with abnormal pacing parameters and abnormal ECG readings

  1 month and 12 months post-procedure

• Changes of cardiac ultrasound values (including LVEF, LVESD and LVEDD)

  12 months post-procedure.

• Changes of NYHA class

  1 month and 12 months post-procedure

• Changes of EQ-5D-5L assessment

  1 month and 12 months post-procedure

Study Arms (1)

Permanent pacemaker implantation or cardiac resynchronization therapy

Patients with an indication for permanent pacemaker implantation or CRT

Device: Solia S and Selectra 3D Developed by BIOTRONIK

Interventions

Solia S and Selectra 3D Developed by BIOTRONIK DEVICE

LBBaP with Solia S and Selectra 3D Developed by BIOTRONIK

Permanent pacemaker implantation or cardiac resynchronization therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an indication for permanent pacemaker implantation or CRT

You may qualify if:

• All patients for whom it is the first time to receive permanent pacemaker implantation or CRT, and on whom LBBaP will be performed for trial.
• Willingness to participate in the investigation and sign the ICF
• Ability and willingness to perform all follow-up visits at the investigation sites

You may not qualify if:

• Age less than 18 years
• Patients with cardiac amyloidosis
• Patients with ventricular hypertrophy (interventricular septum diastolic thickness measured from two-dimensional echocardiography: ≥ 15 mm; or, interventricular septum diastolic thickness for patients with a definite family history: ≥ 13 mm)
• Participating in other intervention clinical trials
• Life-expectancy less than one year
• Pregnancy and/or breast feeding

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, China

RECRUITING

Study Officials

• Chen Keping, Doctor

  Fu Wai Hospital, Chinese Academy of Medical Sciences, Fu Wai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Keping, Doctor

CONTACT

13811266140; chenkepingfw@126.com

Li Jie, Bachelor

CONTACT

13811266140; lijie_mmtchina@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: March 31, 2023
• Study Start: July 4, 2023
• Primary Completion: April 20, 2025
• Study Completion: April 20, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)