NCT04397224

Brief Summary

This prospective multicenter registry study aims to detect the serial changes in ventriculo-ventricular conduction times according to cardiac-resynchronization therapy response.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

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 20, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2024

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

4 years

First QC Date

May 17, 2020

Last Update Submit

June 29, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Serial change of ventriculo-ventricular conduction times

    Reduction or extension of ventriculo-ventricular conduction times

    from enrollment to last follow-up (2 years)

Study Arms (2)

CRT responder

Diagnostic Test: Device interrogation

CRT non-responder

Diagnostic Test: Device interrogation

Interventions

Device interrogationDIAGNOSTIC_TEST

Ventriculo-ventricular conduction time measurement using device analyzer

CRT non-responderCRT responder

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart failure patients implanted with multipoint pacing CRT device and quadripolar left ventricular lead from Abbott

You may qualify if:

  • meeting the current ESC or ACCF/AHA/HRS Class I or Class IIa indications for cardiac-resynchronization (CRT) implant

You may not qualify if:

  • Myocardial infarction, unstable angina within 40 days prior the enrollment
  • Recent cardiac revascularization in the 4 weeks prior to the enrollment or planned for the 3 months following
  • Cerebrovascular accident (CVA) or transient ischemic attack (TIA) in the 3 months prior to the enrollment
  • Primary valvular disease requiring surgical correction
  • Pregnant or are planning during the duration of the investigation
  • Status 1 candidate for cardiac transplantation or consideration for transplantation over the next 12 months
  • Post-cardiac transplantation
  • Life expectancy \< 12 months
  • Currently participating in any other clinical investigation except for observational registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Sejong General Hospital

Bucheon-si, South Korea

RECRUITING

Samsung Changwon Medical Center

Changwon, South Korea

RECRUITING

Chungnam National University Hospital

Daejeon, South Korea

RECRUITING

Eulji University Hospital

Daejeon, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2020

First Posted

May 21, 2020

Study Start

July 20, 2018

Primary Completion

July 20, 2022

Study Completion

July 20, 2024

Last Updated

June 30, 2021

Record last verified: 2021-06

Locations