NCT06221384

Brief Summary

Modified TAPSE (m-TAPSE) is a new method in which TAPSE is measured by taking the difference between the apical and lateral tricuspid annulus distance during diastole and systole. It can be measured using transesophageal echocardiography (TEE) in the mid-esophageal four-chamber (ME 4CH) view and is an alternative easily measurable parameter for intraoperative assessment of RV systolic function as long as optimal imaging quality is achieved. In this prospective observational study, between 01.02.2024 and 01.01.2025, patients between the ages of 1-18 will undergo transcatheterization procedures using TTE and TEE under anesthesia by a pediatric cardiologist. TAPSE of these patients will be measured by TTE and TEE. TAPSE of the patients will be evaluated with TTE and TOE.

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
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

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

January 15, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

July 30, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

January 15, 2024

Last Update Submit

July 29, 2024

Conditions

We Aim to Compare Modified Tricuspid Annular Plane Systolic Excursion With Tricuspid Annular Plane Systolic Excursion

Keywords

TAPSEModified TAPSEPediatric

Outcome Measures

Primary Outcomes (1)

  • echo

    Intraoperatively, TAPSE and modified TAPSE values of patients will be measured.

    30 minute

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Transcatheterization procedures using TTE and TEE under anesthesia will be performed by pediatric cardiologist between the ages of 1-18.

You may qualify if:

  • Hastanın 1-18 yaş arasında olması 2- Pediyatrik kardiyak transkataterizasyon işlemi yapılması 3- ASA 1-3 hastalar

You may not qualify if:

  • Veli veya vasinin onay vermemesi 2- ASA 4 ve üzeri hastalar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ferdi Gülaştı

Aydin, 09020, Turkey (Türkiye)

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant prof.dr.

Study Record Dates

First Submitted

January 15, 2024

First Posted

January 24, 2024

Study Start

February 1, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2026

Last Updated

July 30, 2024

Record last verified: 2024-01

Locations

TU(1)