| CTRI Number |
CTRI/2025/09/094194 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Diagnostic Accuracy Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Diagnostic Test Accuracy for Measuring Heart Size |
|
Scientific Title of Study
|
A Comparative Study of Contrast Computed Tomography and Transesophageal Echocardiography for Assessing Left Atrial Appendage Dimensions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anandamoyee Dhar |
| Designation |
Associate Director, Radiology |
| Affiliation |
MAX Healthcare |
| Address |
Department of Radio Imaging, Ground Floor, West Block, Max Super Speciality Hospital, Saket
1, Press Enclave Road
Saket, New Delhi
South DELHI 110017 India |
| Phone |
9810418279 |
| Fax |
|
| Email |
anandmoyee.dhar@maxhealthcare.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anandamoyee Dhar |
| Designation |
Associate Director, Radiology |
| Affiliation |
MAX Healthcare |
| Address |
Department of Radio Imaging, Ground Floor, West Block, Max Super Speciality Hospital, Saket
1, Press Enclave Road
Saket, New Delhi
Bijapur DELHI 110017 India |
| Phone |
9810418279 |
| Fax |
|
| Email |
anandmoyee.dhar@maxhealthcare.com |
|
Details of Contact Person Public Query
|
| Name |
Pankaj Lakhwan |
| Designation |
Senior Clinical Scientist |
| Affiliation |
nference Labs Private Limited |
| Address |
3rd, 4th and 5th Floor, Indiqube Golf View Homes, 3rd Cross, Rustam Bagh Layout, NAL Wind Tunnel Main Road, Murugeshpalya, Bengaluru, Karnataka
Bangalore KARNATAKA 560017 India |
| Phone |
9654569437 |
| Fax |
|
| Email |
pankaj.lakhwan@anumana.ai |
|
|
Source of Monetary or Material Support
|
| nference Labs Private Limited, 4th & 5th Floor, Indiqube, Golf View Campus Tower-2, 22, 3rd Cross Rd, Murugeshpalya, S R Layout, Rustam Bagh Layout, Bengaluru, Karnataka 560017 |
|
|
Primary Sponsor
|
| Name |
nference Labs Private Limited |
| Address |
3rd, 4th and 5th Floor, 3rd Cross, Indiqube Golf View Homes Rustam Bagh Layout, NAL Wind Tunnel Main Road, Murageshpalya , Bangalore North, Karnataka, India - 560017 |
| Type of Sponsor |
Other [Medical Device] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anandamoyee Dhar |
Max Healthcare Ethics Committee |
Department of Radio Imaging, Ground Floor, West Block, Max Super Speciality Hospital, Saket
1, Press Enclave Road
Saket, New Delhi
New Delhi DELHI |
9810418279
anandmoyee.dhar@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MaX Healthcare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I489||Unspecified atrial fibrillation and atrial flutter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing TEE who require Cardiac CT, as indicated medically. |
|
| ExclusionCriteria |
| Details |
Patients with cyanoic congenital heart disease
Patients who have undergone LAA appendage closure
Hemodynamically unstable patient
Acute/chronic kidney disease
Suspected esophageal varices
Upper GI bleed
International Normalized Ratio greater than 1.5
Past history of allergic or anaphylaxis to contrast
Age less than 18 years
Irregular rhythm where gating is not possible.
Non-consenting patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Inter modality agreement mean bias and 95 percent limits of agreement on Bland Altman analysis for LAA ostium diameter and LAA depth between TEE and CT. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlate anatomical types & location of left atrial appendage identified by TEE with Contrast Cardiac CT. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Accurate sizing of the left atrial appendage (LAA) is essential for selecting the appropriate device during percutaneous LAA occlusion procedures and for planning electrophysiology interventions.
Transesophageal echocardiography (TEE) is commonly used during procedures because of its excellent temporal resolution and ability to visualize the appendage. However, its semi-invasive nature and limited foreshortening can affect measurement accuracy.
Multidetector computed tomography (CT) offers high spatial resolution and the ability to perform true-orthogonal reformatting, which allows for precise assessment of complex LAA anatomy. CT measurements, however, can be influenced by factors such as the timing of the contrast bolus and cardiac phase (Sattar Y et al., 2022).
This prospective, blinded study compares TEE with contrast-enhanced CT for assessing LAA dimensions. The primary endpoint is the agreement between the two modalities in measuring the LAA ostium diameter and appendage depth. This is analyzed using Bland-Altman analysis, with CT serving as the spatial reference due to its high isotropic resolution (Soh BWT et al., 2024).
Secondary endpoints include comparing LAA morphological subtypes and location classification between the two imaging methods.
We will enroll adult patients who are already scheduled for routine TEE and a prescribed cardiac CT. Eligible participants will receive an additional contrast-enhanced cardiac CT at no cost, performed during the same clinical visit or within 48 hours to avoid anatomical changes.
Two independent readers, each focused on a specific imaging modality and blinded to each other’s results and clinical data, will measure the LAA ostium diameter and depth using predefined anatomical landmarks. All data will be securely stored for later statistical analysis, allowing a direct comparison of imaging results and an evaluation of TEE performance under blinded conditions. |