NCT04051814

Brief Summary

This is a retrospective study of our patient population implanted with the Medtronic's Leadless single-chamber ventricular pacemakers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 31, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

5.8 years

First QC Date

August 8, 2019

Last Update Submit

February 27, 2023

Conditions

Pacemaker

Outcome Measures

Primary Outcomes (1)

  • Complication Rate

    We plan to collect data to determine the acute overall complication rate

    2 years

Interventions

Micra Transcatheter Pacemaker SystemOTHER

A miniaturized single chamber pacemaker system that is delivered via catheter through the femoral vein and is implanted directly inside the right ventricle of the heart

Eligibility Criteria

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

All Patients scheduled to be implanted with a leadless pacemaker

You may qualify if:

  • All Patients scheduled to be implanted with a leadless pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

RECRUITING

Central Study Contacts

Leila Andres, MS

CONTACT

949-764-4510clinicalresearch@hoag.org

Colleen Balius

CONTACT

949-764-1497colleen.balius@hoag.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Data Coordinator

Study Record Dates

First Submitted

August 8, 2019

First Posted

August 9, 2019

Study Start

July 31, 2019

Primary Completion

May 15, 2025

Study Completion

May 15, 2025

Last Updated

February 28, 2023

Record last verified: 2023-02

Locations

US(1)