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CTRI Number  CTRI/2025/07/091541 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   CRHD With Persistent Atrial Fibrillation 
Scientific Title of Study   Long term outcome of patients with symptomatic rheumatic atrial fibrillation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Daljeet kaur saggu 
Designation  Cosultant Cardiologist and Electrophysiologist 
Affiliation  AIG Hospitals 
Address  Gachibowli,hyderabad
Gachibowli,hyderabad
Hyderabad
TELANGANA
DrDaljeet Kaur Saggu
India 
Phone  918978428938  
Fax    
Email  drdaljeetsaggu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Daljeet kaur saggu 
Designation  Cosultant Cardiologist and Electrophysiologist 
Affiliation  AIG Hospitals 
Address  Gachibowli,hyderabad
Gachibowli,hyderabad
Hyderabad
TELANGANA
DrDaljeet Kaur Saggu
India 
Phone  918978428938  
Fax    
Email  drdaljeetsaggu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Daljeet kaur saggu 
Designation  Consultant Cardiologist 
Affiliation  AIG Hospitals 
Address  Gachibowli,hyderabad
Gachibowli,hyderabad
Hyderabad
TELANGANA
DrDaljeet Kaur Saggu
India 
Phone  918978428938  
Fax    
Email  drdaljeetsaggu@gmail.com  
 
Source of Monetary or Material Support  
AIG Hospitals 
 
Primary Sponsor  
Name  Asian health Care Foundation 
Address  Gachibowli,hyderabad 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrDaljeet Kaur Saggu  AIG Hospitals,Department of Cardiology  Gachibowli,hyderabad,India-500032 04042444244
Hyderabad
TELANGANA 		 918978428938

drdaljeetsaggu@gmail.com 
Dr Sourya Acharya  Jawaharlal Nehru Medical Institute,Department of Cardiology  Sawangi, Meghe, India.
Wardha
MAHARASHTRA 		 09511840372

souryaacharya74@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-AIG  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: I088||Other rheumatic multiple valve diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Direct Current Cardioversion and Pacemaker Implantation with AV Junction ablation  Direct Current Cardioversion and Pacemaker Implantation with AV Junction ablation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  CRHD patients with Atrial Fibrillation 
 
ExclusionCriteria 
Details  Non-Rheumatic patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study improvement in exercise capacity as measured by 6-minute walk test distance (6MWT) following systematic management of symptomatic RHDAF patients.  minimum one-year follow-up 
 
Secondary Outcome  
Outcome  TimePoints 
1. To Study change in functional class over 1year follow-up.
2. To study improvement in cardiac biomarker NT-proBNP over 1year follow-up.
3. To study number of heart failure related hospital admissions over 1year follow-up.
4. To study improvement in left ventricular ejection fraction (modified Simpson’s method)/pulmonary artery systolic pressure (PASP)/tricuspid regurgitation/Mitral regurgitation/left atrial volume and dimension over 1year follow-up.
 		 over a period of 1 year follow up 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   25/08/2025 
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="2"
Months="5"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drdaljeetsaggu@gmail.com].

  6. For how long will this data be available start date provided 25-07-2025 and end date provided 30-03-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Rheumatic heart disease (RHD) continues to be an important cause of (42%) of atrial fibrillation (AF) in India (1). Atrial fibrillation in RHD affects younger patients ( 51.24 ± 15.36 years) compared to Non-valvular AF reported from the western  population (2). This will have a significant socio economic implication because of the disability�’adjusted life years (DALYs).

The first Indian registry, the Indian Heart Rhythm Society (IHRS) atrial fibrillation (AF) studied 1000 patients with AF at twenty different cities across the country. It showed rheumatic heart disease (RHD) as the leading cause of (42%) of AF in India (1). In an Indian study, age of AF patients were 51.24 ± 15.36 years which is much younger than the western population (2). This emphasizes the huge economic implication because of the disability�’adjusted life years (DALYs) and need to adequately address the treatment of AF effectively.

 
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