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CTRI Number  CTRI/2025/08/092733 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Diagnostic Accuracy Study 
Study Design  Other 
Public Title of Study   Comparison of diagnostic test accuracy for the detection of blood clots in the heart 
Scientific Title of Study   A Comparative Study of Contrast CT and Transesophageal Echocardiography for Left Atrial Appendage Thrombus Detection  
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 Satish Govind 
Designation  Head of Non-Invasive Cardiology 
Affiliation  Narayana Health 
Address  Narayana Institute of Cardiac Sciences, Narayana Health, Bengaluru

Bangalore
KARNATAKA
560099
India 
Phone  9845176922  
Fax    
Email  drsatish.govind@narayanahealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Satish Govind 
Designation  Head of Non-Invasive Cardiology 
Affiliation  Narayana Health 
Address  Ground Floor, Head of Department Office, Department of Non Invasive Cardiology, Narayana Institute of Cardiac Sciences
258/A, Bommasandra Industrial Area, Anekal Taluk, Hosur Road, Bangalore, Karnataka - 560099
Bangalore
KARNATAKA
560099
India 
Phone  9845176922  
Fax    
Email  drsatish.govind@narayanahealth.org  
 
Details of Contact Person
Public Query
 
Name  Pankaj Lakhwan 
Designation  Senior Clinical Scientist 
Affiliation  nference Labs Private Limited 
Address  3rd, 4th & 5th Floor, Indiqube Golf View Homes, 3rd Cross, Rustam Bagh Layout, NAL Wind Tunnel Main Road, Murugeshpalya, Bengaluru, Karnataka 560017

Bangalore
KARNATAKA
421204
India 
Phone  09845176922  
Fax  9654569437  
Email  pankaj.lakhwan@anumana.ai  
 
Source of Monetary or Material Support  
nference Labs Private Limited, 3rd, 4th and 5th Floor, Indiqube Golf View Homes, 3rd Cross, Rustam Bagh Layout, NAL Wind Tunnel Main Road, Murugeshpalya, Bengaluru, Karnataka 560017, India 
 
Primary Sponsor  
Name  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 560017 
Type of Sponsor  Other [Medical Device Industry] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Satish Govind  Narayana Institute of Cardiac Sciences  Department of Non Invasive Cardiology, Ground Floor, Narayana Institute of Cardiac Sciences, 258/A, Bommasandra Industrial Area, Anekal Taluk, Hosur Road, Bangalore, Karnataka - 560099
Bangalore
KARNATAKA 
09845176922

drsatish.govind@narayanahealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Health Medical 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 with atrial fibrillation or any other indications for LAA thrombus screening referred for routine Transesophageal echocardiogram

and Contrast Computed Tomography.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The accuracy, sensitivity and specificity of Transesophageal Echocardiography (TEE) in detecting left atrial appendage (LAA) thrombus, evaluated against Contrast Cardiac CT as the reference standard
 
Only at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Correlate anatomical types & location of left atrial appendage (LAA) identified by Transesophageal Echocardiography (TEE) in comparison with Contrast Cardiac CT as reference standard
 
Only at 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)   19/08/2025 
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  
  • This investigation is a prospective, blinded comparison study in which adult patients (more than 18 years)  requiring evaluation for left atrial appendage (LAA) thrombus will undergo both Transesophageal Echocardiography (TEE) and Contrast Cardiac CT as per standard of care. Patients are enrolled following confirmation that they meet inclusion criteria, such as having atrial fibrillation and being suitable candidates for both TEE and CT. After informed consent is obtained, TEE is performed under routine clinical conditions. Subsequently, within a defined interval to minimize clinical changes, patients receive a Contrast Cardiac CT according to standardized cardiac imaging protocols. The TEE interpreter is blinded to the CT findings, while the CT images are evaluated by a separate cardiac imaging specialist unaware of TEE results.

  • The primary endpoint is the accuracy, sensitivity and specificity of TEE in detecting LAA thrombus, using CT as the reference standard. The sole secondary endpoint included in this study is correlating the anatomical types and location of the left atrial appendage (LAA) identified by TEE with those observed on CT, thereby assessing the consistency of structural characterization between the two modalities. All relevant findings are captured in a secure database for subsequent statistical analysis, enabling a direct comparison of imaging results and a clear evaluation of TEE performance under rigorous, blinded conditions.

 
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