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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  
Name  Address 
NIL   
 
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  
Status 
Not Applicable 
 
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.

 
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