NCT04738396

Brief Summary

This is a multi-site, non-randomized, data collection study. The purpose of this study is to investigate the cardiac electrical and mechanical function during LBBAP with different AV intervals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

4 active sites

Status
completed

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

December 29, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2022

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

February 1, 2021

Last Update Submit

February 20, 2023

Conditions

Cardiac PacingPacing Therapy

Outcome Measures

Primary Outcomes (1)

  • ECG QRS duration

    The primary endpoint is QRS duration during LBBP

    At least 3 months post implant

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who received LBBAP for at least 3 months and come back to hospital for regular follow-up will be considered to be recruited voluntarily.

You may qualify if:

  • Patients aged from 18 to 80 years old
  • Patients who are willing to provide Informed Consent
  • Patients who received LBBAP for at least 3 months
  • Patients' implanted device can provide intracardiac electrograms
  • Bradycardia patients with AVB or heart failure patients with LBBB

You may not qualify if:

  • Patients who are pregnant or have a plan for pregnancy during the study
  • Patients with persistent AF
  • Patients who have medical conditions that would limit study participation
  • Patients who were already enrolled in other clinical trial which would impact his/her participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Zhejiang Greentown Cardiovascular Hospital

Hangzhou, Zhejiang, 310011, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310020, China

Location

Study Officials

  • Xiaohong Zhou

    Medtronic

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 4, 2021

Study Start

December 29, 2020

Primary Completion

September 6, 2022

Study Completion

December 8, 2022

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations

CN(4)