| 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
|
|
|
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
|
|
|
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
|
|
|
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.5 In this study we determine the short-term and long-term outcomes of these three treatment modalities namely surgery, PETROS and Fibrinolysis. |