| CTRI Number |
CTRI/2017/08/009372 [Registered on: 16/08/2017] Trial Registered Prospectively |
| Last Modified On: |
06/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
PRESERVE-Mitral Post-Market Registry or
Prospective REgistry to Study Clinical OutcomEs of Repair of Mitral ValvEs in South Asia.
|
|
Scientific Title of Study
|
Prospective REgistry to Study Clinical OutcomeEs of Repair of Mitral ValvEs in South Asia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinay Rajan |
| Designation |
Clinical Research Manager |
| Affiliation |
India Medtronic Pvt. Ltd. |
| Address |
India Medtronic Pvt. Ltd.
Solitaire Corporate Park
Bldg No. 12 4th Floor
Andheri Ghatkopar Link Road, Andheri (e)
Mumbai
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02233074700 |
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinay Rajan |
| Designation |
Clinical Research Manager |
| Affiliation |
India Medtronic Pvt. Ltd. |
| Address |
India Medtronic Pvt. Ltd.
Solitaire Corporate Park
Bldg No. 12 4th Floor
Andheri Ghatkopar Link Road, Andheri (e)
Mumbai
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02233074700 |
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinay Rajan |
| Designation |
Clinical Research Manager |
| Affiliation |
India Medtronic Pvt. Ltd. |
| Address |
India Medtronic Pvt. Ltd.
Solitaire Corporate Park
Bldg No. 12 4th Floor
Andheri Ghatkopar Link Road, Andheri (e)
Mumbai
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02233074700 |
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
|
Source of Monetary or Material Support
|
| India Medtronic Pvt. Ltd.
Solitaire Corporate Park, Bldg No. 12, 4th Floor
Andheri Ghatkopar Link Road, Andheri (e)
Mumbai, Maharashtra - 400093
India |
|
|
Primary Sponsor
|
| Name |
Medtronic Plc |
| Address |
Clinical Research
Mailstop: MVS66
Mounds View South
8200 Coral Sea St NE
Mounds View, MN 55112 |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| India Medtronic Pvt Ltd |
India Medtronic Pvt. Ltd.
Solitaire Corporate Park, Bldg No. 12, 4th Floor
Andheri Ghatkopar Link Road, Andheri (e)
Mumbai, Maharashtra - 400093
|
|
|
Countries of Recruitment
|
Nepal
Bangladesh
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Praveen Varma PK |
Amrita Institute of Medical Sciences |
Peeliyadu Road, Ponekkara, Edappally,
Ernakulam ,
Kochi-682041
Ernakulam
KERALA |
914842801234
praveenv21204@aims.amrita.edu |
| Dr Gutti Rama Subrahmanyam |
Care Hospital |
Care Hospital, Banjara Hills, Road No 1, Hyderabad-500034, Telangana
Hyderabad
ANDHRA PRADESH |
9849021975
d_gutti@rediffmail.com |
| Dr Anil Jain |
EPIC Hospital |
EPIC Hospital ( Unit of Vatsalya Healthcare LLP)
Empire Doctor House, Sarkhej - Gandhinagar Hwy, opp. Kargil Petrol Pump
Ahmedabad
Gujarat, 380060
India
Gandhinagar
GUJARAT |
9443047152
dranilrjain@yahoo.co.in |
| Dr Chandrashekhar Padmanabham |
G. Kuppuswamy Naidu Memorial Hospital |
G. Kuppuswamy Naidu Memorial Hospital, No. 6327, Nethaji Road, Pappanaickenpalayam, Coimbatore-641037, Tamil Nadu
Coimbatore
TAMIL NADU |
9443047152
chanpad@gmail.com |
| Dr Anbarasu Mohanraj |
Madras Medical Mission |
4A Dr J J Nagar, Mogappair Chennai 600037
Chennai
TAMIL NADU |
044265680004407
anbarasu.mohanraj@gmail.com |
| Dr Bhagwan Koirala |
Manmohan Cardiothoracic Vascular and Transplant Centre,Tribhuvan University |
TU Teaching Hospital, Maharajgunj Rd, Khatmandu 44600, Nepal
|
919851111055
koiralabhagawan@gmail.com |
| Dr Priyankar Sinha |
Narayana Institute of Cardiac Sciences |
Taluk, Anekal, 258/A, Hosur Rd, Bommasandra Industrial Area , Bangalore
Bangalore
KARNATAKA |
9825007068
drpriyankarsinha@gmail.com |
| Dr Haroon Rasheed |
National Heart Foundation & Research Institute |
Mirpur 2
Dhaka
|
01819297559
dr.h.rasheed@gmail.com |
| Dr Prasanna Simha M |
Sri Jayadeva Institute of Cardiovascular Sciences & Research |
Bannerghatta Main Rd, Phase 3, Jayanagara 9th Block,
Bangalore-560069
Bangalore
KARNATAKA |
9341216294
prasannasimha@gmail.com |
| Dr Chirag Doshi |
U.N. Mehta Institute of Cardiology & Research Center |
Gate No. 1, Civil Hospital, Asarwa,
Ahmedabad Gujarat 380016
Ahmadabad
GUJARAT |
9099973490
drchiragdoshi@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Ethic Committee, All India Institute of Medical Sciences |
Submittted/Under Review |
| Ethics Committee of Shreeji Hopsital |
Approved |
| Institutional Ethics Commitee for Human Research Star Hospitals |
Approved |
| Institutional Ethics Commitee, Hinduja Hospital |
Approved |
| Institutional Ethics Committee Amrita Institute of Medical Sciences and Research Centre |
Approved |
| Institutional Ethics Committee , Care Hospital |
Approved |
| Institutional Ethics Committee of BJ Medical College & Civil Hospital |
Approved |
| Institutional Ethics Committee, GKNM |
Approved |
| Institutional Ethics Committee, SAL Hospital and Medical Institute |
Approved |
| Institutional Ethics Committee, The Madras Medical Mission |
Approved |
| Narayana Health Medical Ethics Commitee |
Approved |
| National Heart Foundation Hospital & Research Institute |
Approved |
| Nepal Health Research Council |
Approved |
| Sri Jayadeva Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure as part of standard care, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with valvular insufficiency and/or stenosis and indicated for the reconstruction and/or remodeling of pathological mitral valves with Profile 3DTM and CG Future annulopasty systems.
2) Indications and contraindications provided in the product Instructions for Use
3) Subject is 18 years of age or older
4) The patient or his/her Legally Authorised Representative ( LAR) has been informed about the nature of the registry and the patient informed consent for study participation has been obtained prior to performing any study-related procedures from the subject or Legally Authorized Representative, as per applicable local requirements. |
|
| ExclusionCriteria |
| Details |
1. Contraindications as per IFU:
a. Heavily calcified valves
b. Valvular retraction with severely reduced mobility
c. Active bacterial endocarditis
2. Aortic valve replacement as concomitant procedure
3. Already participating in another clinical study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products ( Profile 3DTM and CG Future annuloplasty systems) in the approved intended use up to 12 months from the day of procedure. |
12 months post procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Characterize the demographics of the patients undergoing mitral valve repair using annuloplasty systems in South Asia, and assess the functional and procedural outcomes of the procedure. |
Discharge, 3-6 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="150"
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
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
11/10/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/10/2017 |
| 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)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Objective "o" |