| CTRI Number |
CTRI/2024/05/067520 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To compare changes in right atrial and ventricular dimensions with functions pre and post ASD device closure and after 1,3 and 6 months of procedure in patients of ASD |
|
Scientific Title of Study
|
Right atrial and ventricular dimensions with functions pre and post device closure; in patients of ASD at 1 , 3 and 6 months of procedure |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anuj Chaturvedi |
| Designation |
Senior Resident |
| Affiliation |
Jawaharlal Nehru medical college , sawangi meghe wardha |
| Address |
Cardiology department,Jawaharlal Nehru medical college , sawangi meghe wardha
wardha
Maharastra
442001
INDIA
Wardha
MAHARASHTRA
442001
India |
| Phone |
9770435883 |
| Fax |
|
| Email |
anujthedoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gajendra Agrawal |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru medical college , sawangi meghe wardha |
| Address |
Cardiology department,Jawaharlal Nehru medical college , sawangi meghe wardha
wardha
Maharastra
442001
INDIA
Wardha
MAHARASHTRA
442001
India |
| Phone |
9552212800 |
| Fax |
|
| Email |
gajendramanakshe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anuj Chaturvedi |
| Designation |
Senior Resident |
| Affiliation |
Jawaharlal Nehru medical college , sawangi meghe wardha |
| Address |
Cardiology department,Jawaharlal Nehru medical college , sawangi meghe wardha
wardha
Maharastra
442001
INDIA
Wardha
MAHARASHTRA
442001
India |
| Phone |
9770435883 |
| Fax |
|
| Email |
anujthedoc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal nehru medical college , sawangi meghe , wardha 442001 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College, Sawangi Meghe , Wardha |
| Address |
Sawangi Meghe , Wardha ,Maharashtra, 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Anuj Chaturvedi |
Jawaharlal Nehru Medical College |
Department of Cardiology,Jawaharlal Nehru Medical College , Datta Meghe Institute of Higher Education and Research , Wardha , Maharashtra .
Wardha
MAHARASHTRA |
9770439883
anujthedoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All ASD patients coming to CARDIOLOGY OPD and IPD patients in the age group of 3 years and above undergoing percutaneous device closure of ASD in our institute |
|
| ExclusionCriteria |
| Details |
Patients not fit for percutaneous device closure and requiring open heart surgery |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to describe changes in RV physiology over a follow-up period of 6 months in adults and children who will be undergoing catheter device closure of an ASD . |
6 months post ASD device closure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| study of right atrial and ventricular form and functions pre and post device closure in patients of ASD and its clinical and morphological outcome and also biatrial effect of device closure. |
6 months post ASD device closure |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The focus of this investigation is to describe and compare changes in RV and RA physiology ,along with biatrial effect over a follow-up period of 6 months in adults and children who will be undergoing catheter device closure of an ASD. very few such studies have been done in india till now and ASD device closure has the advantage of avoiding the need for sternotomy , and ICU stay and permits rapid recovery , with its associated economic and social benefits |