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CTRI Number  CTRI/2024/05/067331 [Registered on: 14/05/2024] Trial Registered Prospectively
Last Modified On: 30/04/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Comparison of 30 days all-cause death of patients who are treated with balloon procedure (PETROS) vs. clot-dissolving medicines in patients with stuck mechanical heart valves 
Scientific Title of Study   STUCK VALVE REGISTRY TRIAL 
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 Nandhakumar Vasu 
Designation  Consultant Cardiology 
Affiliation  The Madras Medical Mission  
Address  The Madras Medical Mission Institute of Cardiovascular disease Room no 24 4th floor 4 A Dr J Jayalalitha Nagar Mogappair Chennai

Chennai
TAMIL NADU
600037
India 
Phone  9952516668  
Fax  914426565974  
Email  nandha.intervention@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nandhakumar Vasu 
Designation  Consultant Cardiology 
Affiliation  The Madras Medical Mission  
Address  The Madras Medical Mission Institute of Cardiovascular disease Room no 24 4th floor 4 A Dr J Jayalalitha Nagar Mogappair Chennai

Chennai
TAMIL NADU
600037
India 
Phone  9952516668  
Fax  914426565974  
Email  nandha.intervention@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nandhakumar Vasu 
Designation  Consultant Cardiology 
Affiliation  The Madras Medical Mission  
Address  The Madras Medical Mission Institute of Cardiovascular disease Room no 24 4th floor 4 A Dr J Jayalalitha Nagar Mogappair Chennai

Chennai
TAMIL NADU
600037
India 
Phone  9952516668  
Fax  914426565974  
Email  nandha.intervention@gmail.com  
 
Source of Monetary or Material Support  
The Madras Medical Mission Hospital, 4-A, Dr.J.Jayalalitha Nagar, Mogappair, Chennai, Tamilnadu, India. Pincode:600037 
 
Primary Sponsor  
Name  The Madras Medical Mission 
Address  4 A Dr J Jayalalitha Nagar Mogappair Chennai 600037 
Type of Sponsor  Private hospital/clinic 
 
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 Nandhakumar Vasu  The Madras Medical Mission  Room no:24, fourth floor, Department of Cardiology, The Madras Medical Mission 4 A Dr J Jayalalitha Nagar Mogappair Chennai 600037
Chennai
TAMIL NADU 
9952516668
914426565974
nandha.intervention@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee The Madras Medical Mission No 4 A Dr J J Nagar Mogappair Chennai 600037  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I083||Combined rheumatic disorders of mitral, aortic and tricuspid valves, (2) ICD-10 Condition: I341||Nonrheumatic mitral (valve) prolapse, (3) ICD-10 Condition: I350||Nonrheumatic aortic (valve) stenosis, (4) ICD-10 Condition: I998||Other disorder of circulatory system, (5) ICD-10 Condition: I351||Nonrheumatic aortic (valve) insufficiency, (6) ICD-10 Condition: I340||Nonrheumatic mitral (valve) insufficiency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  The patients who underwent repeat surgery, fibrinolysis or PETROS for stuck valve from First January 2019 till the CTRI registration of this registry will be included retrospectively. From the completion of CTRI registration the participants will be included prospectively till 2029. 
 
ExclusionCriteria 
Details  Not willing to participate. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
All-cause mortality   30days 
 
Secondary Outcome  
Outcome  TimePoints 
All-cause mortality  one-year 
 
Target Sample Size   Total Sample Size="1204"
Sample Size from India="1204" 
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)   30/05/2024 
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="10"
Months="0"
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  

Mechanical heart valves are recommended in mitral valve disease patients aged <65 years or aortic valve disease patients aged <60 years with a reasonable life expectancy and no contraindications to long-term anticoagulation.1 This recommendation was made because of the durability of the mechanical prosthesis over bioprosthesis. However, the durability of the mechanical valve is often challenged by obstructive thrombus as early as the first year. Redo surgery or fibrinolysis in high-risk surgery patients is the currently available evidence-based treatment.1Percutaneous transcatheter release of stuck valve (PETROS) with cerebral embolic protection for left sided mechanical valves is the upcoming therapeutic modality.2,3 The mechanical heart valve thrombosis incidence ranges from 0.1% to 5.7%.4 Redo cardiac surgery often ends in a new valve replacement with a bioprosthetic valve, though few reports of thrombus removal or pannus removal are available in the literature.4 Ultra-slow infusion of fibrin-specific fibrinolytic agent has shown promise over bolus fibrinolysis. Yet, the failure to release the stuck leaflets or embolic stroke and systemic embolism were seen as dreadful complications.In this study we determine the short-term and long-term outcomes of these three treatment modalities namely surgery, PETROS and Fibrinolysis.

 

 

 
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