NCT04697797

Brief Summary

The aim of this study is to evaluate mechanical and electrical cardiac dyssynchrony in patients with pacemakers and the right ventricular electrode implanted in His Bundle area.

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 Dec 2020

Typical duration 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

First Submitted

Initial submission to the registry

December 14, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

December 14, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

1.9 years

First QC Date

December 14, 2020

Last Update Submit

November 2, 2022

Conditions

Bradyarrhythmia

Keywords

His Bundle PacingDyssynchronyEchocardiographyECG

Outcome Measures

Primary Outcomes (12)

  • Interventricular mechanical delay

    InterVentricular Mechanical Dyssynchrony Parameter 1

    Mid-term: 3-6 months after pacemaker implantation

  • Interventricular mechanical delay

    InterVentricular Mechanical Dyssynchrony Parameter 1

    Long term: 12-15 months after pacemaker implantation

  • Free-wall-LV-to-RV-delay

    InterVentricular Mechanical Dyssynchrony Parameter 2

    Mid-term: 3-6 months after pacemaker implantation

  • Free-wall-LV-to-RV-delay

    InterVentricular Mechanical Dyssynchrony Parameter 2

    Long term: 12-15 months after pacemaker implantation

  • Septal-to-posterior wall motion delay

    IntraVentricular Mechanical Dyssynchrony Parameter 1

    Mid-term: 3-6 months after pacemaker implantation

  • Septal-to-posterior wall motion delay

    IntraVentricular Mechanical Dyssynchrony Parameter 1

    Long term: 12-15 months after pacemaker implantation

  • Opposing wall motion delay

    IntraVentricular Mechanical Dyssynchrony Parameter 2

    Long term: 12-15 months after pacemaker implantation

  • Opposing wall motion delay

    IntraVentricular Mechanical Dyssynchrony Parameter 2

    Mid-term: 3-6 months after pacemaker implantation

  • systolic dyssynchrony index

    Ventricular Mechanical Dyssynchrony Parameter 1

    Long term: 12-15 months after pacemaker implantation

  • systolic dyssynchrony index

    Ventricular Mechanical Dyssynchrony Parameter 1

    Mid-term: 3-6 months after pacemaker implantation

  • QRS duration

    Electrical dyssynchrony Parameter

    Mid-term: 3-6 months after pacemaker implantation

  • QRS duration

    Electrical dyssynchrony Parameter

    Long term: 12-15 months after pacemaker implantation

Secondary Outcomes (10)

  • Radial strain

    Mid-term: 3-6 months after pacemaker implantation

  • Radial strain

    Long term: 12-15 months after pacemaker implantation

  • Left Ventricular Ejection Fraction

    Mid-term: 3-6 months after pacemaker implantation

  • Left Ventricular Ejection Fraction

    Long term: 12-15 months after pacemaker implantation

  • Global longitudinal strain

    Mid-term: 3-6 months after pacemaker implantation

  • +5 more secondary outcomes

Interventions

Device ProgrammingOTHER

Intervention includes (1) pacemaker reprogramming (2) echocardiographic parameters acquisition (3) ECG recording

Also known as: Echocardiography, ECG

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with bradyarrhythmia and indications for de novo permanent pacemaker implantation. The decision for pacing lead placement in His Bundle is left for physician discretion. Patients after pacemaker system implantation with His Bundle successfully pacing are to be asked to participate in the study. After having written informed consent obtained patients are to be scheduled for ventricular synchrony evaluation with ECHO and ECG after 3-6 months after implant (mid-term) and after 12 months (long-term).

You may qualify if:

  • all adult patients after implantation of pacemaker system with pacing lead successfully captured His Bundle (selectively or/and nonselectively)

You may not qualify if:

  • not willing or incapable to give written informed consent;
  • previous implanted cardiac electronic device (pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy device)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Electrocardiology Medical University of Lodz

Lodz, 93-216, Poland

RECRUITING

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Krzysztof A Kaczmarek, MD, PhD

CONTACT

+48 42 201 43 60krzysztof.kaczmarek@umed.lodz.pl

Study Design

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

Study Record Dates

First Submitted

December 14, 2020

First Posted

January 6, 2021

Study Start

December 14, 2020

Primary Completion

October 30, 2022

Study Completion

December 31, 2022

Last Updated

November 3, 2022

Record last verified: 2022-11

Locations

PL(1)