NCT04023890

Brief Summary

This is a prospective, single-site, non-randomized, acute feasibility clinical study. The purpose of this study is to explore the electrocardiogram (ECG) characteristics of simultaneous stimulation of right and left bundle branches area.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

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

January 14, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

6 months

First QC Date

July 16, 2019

Last Update Submit

February 5, 2020

Conditions

Cardiac PacingPacing TherapyPacemaker

Outcome Measures

Primary Outcomes (1)

  • QRS duration

    The primary endpoint is QRS duration during bundle branches area pacing

    During implant

Eligibility Criteria

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

This study will enroll subjects who have pacing indications or indications for CRT.

You may qualify if:

  • Aged from 18 to 80 years old
  • Subjects who are willing to provide Informed Consent
  • Subjects who have pacing indications or indications for CRT, and will receive pacemaker or CRT therapy

You may not qualify if:

  • Subjects who have contra-indications for pacing therapy or CRT
  • CRT up-graded subjects
  • Ventricular hypertrophy
  • Subjects who have medical conditions that would limit study participation
  • Subjects who are pregnant or have a plan for pregnancy during the study
  • Subjects who are not willing to provide Informed Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location

Study Officials

  • Xiaohong Zhou, M.D.

    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

July 16, 2019

First Posted

July 18, 2019

Study Start

January 14, 2019

Primary Completion

July 1, 2019

Study Completion

January 31, 2020

Last Updated

February 6, 2020

Record last verified: 2020-02

Locations

CN(1)