A follow up study to evaluate the safety and effectiveness of tissue valve (aortic) among Indian patients

Recruiting

Conditions: Other nonrheumatic aortic valve disorders,

Registration Number: CTRI/2022/08/044557

Lead Sponsor: SRM Institutes for Medical Science SIMS

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 participantâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 250

Inclusion Criteria

1.Patient who have undergone aortic valve replacement with Edwards Inspiris Resilia (EIR) in aortic position either of aortic stenosis/ aortic regurgitation.
Patient who have undergone concomitant procedure along with Aortic valve replacement with EIR.
Age: Above 18 years, both genders.
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.

Exclusion Criteria

1.Infective Endocarditis 2.Paediatric and Congenital Heart Disease.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness and safety of the Aortic Valve Model 11500A are the outcomes measured in the	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.
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	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.
Gradient,Heart Rate,DVI,Acceleration,Time,Velocity Time Integral (Aortic Valve),Mean Gradient,Stroke Volume,EOA,LVOT VTI,LV Mass,IVS â€“ Systole,	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.
Diastole,Posterior Valve â€“ 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 Measures

Name	Time	Method
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

Trial Locations

Locations (15): Apollo Hospital
🇮🇳
Bangalore, KARNATAKA, India
Apollo Hospital, Hyderabad
🇮🇳
Hyderabad, TELANGANA, India
Apollo Main, Chennai
🇮🇳
Chennai, TAMIL NADU, India
Apollo Multispecialty Hospital
🇮🇳
Kolkata, WEST BENGAL, India
Aster Medicity
🇮🇳
Ernakulam, KERALA, India
Epic Hospital
🇮🇳
Ahmadabad, GUJARAT, India
Escorts Heart Institute and Research Center Limited,
🇮🇳
Delhi, DELHI, India
Eternal Hospital,Unit of Eternal Heart Care Centre and Research Institute Pvt. Ltd.
🇮🇳
Jaipur, RAJASTHAN, India
Manipal Hospital, Dwarka/ Human Care Medical Charitable Trust
🇮🇳
Delhi, DELHI, India
Medanta - The Medicity
🇮🇳
Gurgaon, HARYANA, India
Scroll for more (5 remaining)
Apollo Hospital
🇮🇳Bangalore, KARNATAKA, India
Dr Sathyaki Nambala
Principal investigator
9900994696
sathyaki@gmail.com