CTRI/2022/08/044557 [Registered on: 01/08/2022] Trial Registered Prospectively
Last Modified On:
19/10/2022
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Follow Up Study
Study Design
Other
Public Title of Study
A follow up study to evaluate the safety and effectiveness of tissue valve (aortic) among Indian patients
Scientific Title of Study
Prospective, Multi-centric Registry to evaluate the Safety and Effectiveness of Aortic Valve Bio Prosthesis – Indian InspiRis RegIStry -IIRIS
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Bashi V V
Designation
Director and Senior Consultant - Cardiothoracic Surgery
Affiliation
SRM Institutes for Medical Science (SIMS)
Address
SRM Institutes for Medical Science (SIMS)
No 1 Jawaharlal Nehru Salai Vadapalani Chennai 600026
Chennai TAMIL NADU 600026 India
Phone
9840299552
Fax
-
Email
bashivv@hotmail.com
Details of Contact Person Scientific Query
Name
Dr Bashi V V
Designation
Director and Senior Consultant - Cardiothoracic Surgery
Affiliation
SRM Institutes for Medical Science (SIMS)
Address
SRM Institutes for Medical Science (SIMS)
No 1 Jawaharlal Nehru Salai Vadapalani Chennai 600026
Chennai TAMIL NADU 600026 India
Phone
9840299552
Fax
-
Email
bashivv@hotmail.com
Details of Contact Person Public Query
Name
Dr Bashi V V
Designation
Director and Senior Consultant - Cardiothoracic Surgery
Affiliation
SRM Institutes for Medical Science (SIMS)
Address
SRM Institutes for Medical Science (SIMS)
No 1 Jawaharlal Nehru Salai Vadapalani Chennai 600026
Chennai TAMIL NADU 600026 India
Phone
9840299552
Fax
-
Email
bashivv@hotmail.com
Source of Monetary or Material Support
SRM Institutes for Medical Science SIMS
Primary Sponsor
Name
SRM Institutes for Medical Science SIMS
Address
No. 1, Jawaharlal Nehru Salai, Vadapalani, Chennai 600026
Type of Sponsor
Research institution and hospital
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 16
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Sathyaki Nambala
Apollo Hospital
Apollo Hospitals,
154, 11, Bannerghatta Main Rd,
Krishnaraju Layout, Amalodbhavi Nagar,
Panduranga Nagar,
Bengaluru, Karnataka 560076 Bangalore KARNATAKA
9900994696 - sathyaki@gmail.com
Dr AGK Gokhlae
Apollo Hospital, Hyderabad
Apollo Research & Innovations
Auditorium Building, 1st Floor,
Apollo Medical College,
Apollo Hospitals, Jubilee Hills,
Hyderabad, Telangana, India -500096 Hyderabad TELANGANA
9840299552 - drgokhale@drgokhale.com
Dr LF Sridhar
Apollo Main, Chennai
Research Address: Apollo Research and Innovations
Flat no. 1/16 & 1/17, Second floor,
Krishnadeep chambers (Apollo annexe),
#1, Wallance garden, Thousand Lights,
Chennai - 600 006, Tamil Nadu, India. Chennai TAMIL NADU
9840332731 - drsridhar.lf@gmail.com
Dr Vijayshankar
Apollo Main, Chennai
Research Address: Apollo Research and Innovations
Flat no. 1/16 & 1/17, Second floor,
Krishnadeep chambers (Apollo annexe),
#1, Wallance garden, Thousand Lights,
Chennai - 600 006, Tamil Nadu, India.
Chennai TAMIL NADU
9840042624 - vjshankar2000@gmail.com
Dr Sushan Mukhopadhyay
Apollo Multispecialty Hospital
58, Canal Circular Rd, Kadapara, Phool Bagan, Kankurgachi, Kolkata, West Bengal 700054 Kolkata WEST BENGAL
9830030509 - drsushan1964@gmail.com
Dr Manoj P Nair
Aster Medicity
Kuttisahib Road Cheranelloor, South Chittoor, Kochi, Kerala 682027 Ernakulam KERALA
1.Patient who have undergone aortic valve replacement with Edwards Inspiris Resilia
(EIR) in aortic position either of aortic stenosis/ aortic regurgitation.
2. Patient who have undergone concomitant procedure along with Aortic valve
replacement with EIR.
3. Age: Above 18 years, both genders.
4. Subject undergoing redo AVR surgery due to previous mechanical/ bioprosthetic valve
dysfunction/thrombosis (due to non-compliance to anti-coagulation medication)
5. Child-bearing age female patients planning pregnancy
6. Those who are willing to provide consent.
ExclusionCriteria
Details
1.Infective Endocarditis
2.Paediatric and Congenital Heart Disease
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Effectiveness and safety of the Aortic Valve Model 11500A are the outcomes measured in the
study.Effectiveness will be measured in terms of hemodynamic performance confirmed by Echocardiography at Core Lab (SIMS Hospital). The following parameters will be observed:Peak Velocity,Peak
Gradient,Heart Rate,DVI,Acceleration,Time,Velocity Time Integral (Aortic Valve),Mean Gradient,Stroke Volume,EOA,LVOT VTI,LV Mass,IVS – Systole,
Diastole,Posterior Valve – Systole,Diastole,LVIDd and LVIDs.New York Heart Association(NYHA)functional class compared to baseline.
The subsequent follow-up visits will be made after 3 months, 1 year, and annually thereafter
up to 5th year from the date of implant.
Secondary Outcome
Outcome
TimePoints
Safety will be measured with the following descriptive information of early rates and late lineraized rates of Structural valve deterioration,Thrombeembolism,valve thrombosis,all bleeding/ hemorrhage,major bleeding/hemorrhage,all paravalvular leak,major paravalvular leak,non-structural valve deterioration,endocarditis,all cause mortality,valve related mortality,Valve related reoperation,Explant and Haemolysis.
The subsequent follow-up visits will be made after 3 months, 1 year, and annually thereafter
up to 5th year from the date of implant.
Target Sample Size
Total Sample Size="250" Sample Size from India="250" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Background:The number of patients requiring Aortic Valve Replacement (AVR) is increasing due to
prolonged life expectancy. Diseased heart valves can be treated by medication, surgical repair or
surgical replacement. The new valve can either be mechanical or biological. Biological valves
(also called tissue or bioprosthetic valves) are made of tissue, but they may also have some
artificial parts to provide additional support and allow the valve to be sewn in place. Biological
valves can be made from porcine tissue, bovine pericardial tissue, or pericardial tissue from other
species. These valves are safe to insert, durable (lasting from 15 to 20 years), and allow patients
to avoid lifetime use of Anticoagulants (blood thinning medications).
Treatment of Aortic Valvular Heart Disease:
Aortic stenosis and insufficiency can be treated by surgical intervention, including balloon
valvuloplasty, valve repair, and valve replacement. Bioprosthetic heart valves are indicated for
use in patients suffering from valvular heart disease.
Device Indication for use:
The Edwards Pericardial Aortic Bioprosthesis, Model 11500A, is indicated for patients who
require replacement of their native or prosthetic aortic valve. This device is approved by the
Regulatory Authorities and is freely available in the market, and also used by
Cardiothoracic surgeons across India for the last two years.
Risks and Benefits:
The benefits of the Model 11500A are the same as other bioprosthetic valves including
improved valvular function, acute alleviation of symptoms related to valve stenosis or
insufficiency, and/or improved morbidity and mortality. The anticipated additional benefits of
Aortic Valve Model 11500A, are to eliminate the need for rinsing the bioprosthesis prior to
implantation, less exposure to the risks of glutaraldehyde, and elimination of hazardous waste
requiring special disposal.
As with all prosthetic heart valves , complications, due to individual
participant’s reaction to an implanted device, or to physical or chemical changes in the
components, particularly those of biological origin, may occur at varying intervals (hours or
days) necessitating reoperation and replacement of the prosthetic device.
Primary objective:
To find the effectiveness (Hemodynamic performance) and durability of the Pericardial Aortic
Bioprosthesis Model 11500A valve.
Secondary objective:
To assess the safety of the Model 11500A valve including its complications.
Study Design:
Prospective (5 years follow up), Multicentric registry.
Study Site:
15 sites across India (Ahmedabad, Bengaluru, Chennai, Cochin, Delhi, Dwarka, Gurgaon,
Hyderabad, Jaipur, Kolkata, Mumbai, Pune).
Study Participants:
Based on the following inclusion/ exclusion criteria, the participants will be enrolled in the
registry.