| CTRI Number |
CTRI/2025/08/092397 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Prospective Multicentre Study to Assess the Safety and Performance of the Myval Inception Heart Valve System in Patients with Severe Aortic Valve Narrowing (Stenosis) |
|
Scientific Title of Study
|
A prospective, multi-centre, single-arm, real-world study to evaluate the
safety and performance of Myval Inception Transcatheter Heart Valve System in patients with
symptomatic severe native aortic stenosis |
| 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 Ashok Thakkar |
| Designation |
VP-Head of the Department - Clinical Research and Medical Writing |
| Affiliation |
Meril Life Sciences Pvt. Ltd. |
| Address |
Meril Life Sciences Pvt. Ltd., Bilakhia House Survey Number 135/139, Muktanand Marg, Chala, Vapi-396191,
Gujarat, India
Meril Life Sciences Pvt. Ltd., Bilakhia House Survey Number 135/139, Muktanand Marg, Chala, Vapi-396191,
Gujarat, India
Valsad
GUJARAT
396191
India |
| Phone |
912603052100 |
| Fax |
|
| Email |
ashok.thakkar@merillife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Thakkar |
| Designation |
VP-Head of the Department - Clinical Research and Medical Writing |
| Affiliation |
Meril Life Sciences Pvt. Ltd. |
| Address |
Meril Life Sciences Pvt. Ltd., Bilakhia House Survey Number 135/139, Muktanand Marg, Chala, Vapi-396191,
Gujarat, India
Meril Life Sciences Pvt. Ltd., Bilakhia House Survey Number 135/139, Muktanand Marg, Chala, Vapi-396191,
Gujarat, India
Valsad
GUJARAT
396191
India |
| Phone |
912603052100 |
| Fax |
|
| Email |
ashok.thakkar@merillife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Thakkar |
| Designation |
VP-Head of the Department - Clinical Research and Medical Writing |
| Affiliation |
Meril Life Sciences Pvt. Ltd. |
| Address |
Meril Life Sciences Pvt. Ltd., Bilakhia House Survey Number 135/139, Muktanand Marg, Chala, Vapi-396191,
Gujarat, India
Meril Life Sciences Pvt. Ltd., Bilakhia House Survey Number 135/139, Muktanand Marg, Chala, Vapi-396191,
Gujarat, India
Valsad
GUJARAT
396191
India |
| Phone |
912603052100 |
| Fax |
|
| Email |
ashok.thakkar@merillife.com |
|
|
Source of Monetary or Material Support
|
| Meril Diagnostics Private Limited, No.135 2 B and 175 2, Muktanand Marg, Chala, Vapi-396191, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Meril Diagnostics Private Limited |
| Address |
D1-D3 Meril Park, Survey No.135, 2 , B & 174/2, Muktanand Marg, Chala- 396191, Vapi, Gujarat. |
| Type of Sponsor |
Other [Medical Device Company ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepak Davidson |
Caritas Hospital and Institute of Health Sciences |
Thellakom PO Kottayam Kerala India 686630
Kottayam
KERALA |
9447216959
drdeepakdavidson@gmail.com |
| Dr Vijo |
Ernakulam General Hospital State Kerala |
Hospital Rd Marine Drive Ernakulam Kerala 682011
Ernakulam
KERALA |
9495086524
drvijo@gmail.com |
| Dr Mathew Iype |
GMCT Govt. Medical College Thiruvananthapuram |
Govt. Medical College Ulloor Thiruvananthapuram Kerala 695011
Thiruvananthapuram
KERALA |
9847188112
mathewiype2334@gmail.com |
| Dr Rajesh Gopalan Nair |
Govt Medical College Kozhikode |
Medical College Junction 17 Mavoor Rd near Police Station Kozhikode Kerala 673008
Kozhikode
KERALA |
9447290609
drrajeshgnair@gmail.com |
| Dr Asish Kumar Mandalay |
My Hart@ Starcare Hospital |
N H Bypass Junction near Thondayad Kozhikode Kerala 673017
Kozhikode
KERALA |
98954 43390
asishmandalay@gmail.com |
| Dr Chirag Parikh |
Smt S R Mehta & Sir K P Cardiac Institute |
Plot No 96 Road No 31 Sion Matunga Estate Near Gandhi Market King Circle Sion Mumbai 400 022
Mumbai
MAHARASHTRA |
9819760153
parikhcjp@gmail.com |
| Dr Bijulal S |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
Jai Nagar W Rd Chalakkuzhi Thiruvananthapuram Kerala 695011
Thiruvananthapuram
KERALA |
9446590185
bijulal@sctimst.ac.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Commitee-Caritas Hospital |
Approved |
| HUMAN ETHICS COMMITTEE MEDICAL COLLEGE, THIRUVANANTHAPURAM |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE DIABCARE INDIA |
Approved |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
| Vedant Hospital Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I350||Nonrheumatic aortic (valve) stenosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Myval Inception Transcatheter Heart Valve System |
A balloon-expandable transcatheter heart valve system used via transfemoral access to treat symptomatic severe native aortic stenosis. The study will enroll approximately 200 patients across 20 sites in India. Patients will be followed up at 30 days, 1 year, 3 years, and 5 years through clinic visits, and at 2 and 4 years through telephonic follow-up. The total study duration is approximately 5 years. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient more than and equal to 18 years of age.
2. Patient or their legally acceptable representative (LAR) has provided
written informed consent as approved by the Institutional Review Board
(IRB)Independent Ethics Committee (IEC) of the study site to participate
in the study.
3. Patients with symptomatic severe native aortic stenosis who are suitable
for the treatment with Myval Inception THV System as judged by a Investigator and or heart team. |
|
| ExclusionCriteria |
| Details |
1. Patients who are not willing to provide informed consent form, or whose
legal heirs object to their participation in the study
2. Pregnant and/or lactating female patients
3. Any condition, which, in Investigator’s and/or heart team’s opinion would
preclude safe participation of patients in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Early Safety (30 days): Composite of freedom from all-cause mortality, stroke, major bleeding (VARC type 2–4), major vascular or structural complications, AKI (Stage 3/4), moderate/severe aortic regurgitation, new pacemaker implantation, and reintervention related to device.
Clinical Efficacy (1 year): Composite of freedom from all-cause mortality, stroke, and hospitalization due to valve- or procedure-related causes.
|
30 days and 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
All cause mortality
All stroke
Acute kidney injury
Conduction disturbances and arrhythmias
Vascular and access related complications
Moderate or severe prosthetic valve regurgitation
New permanent pacemaker implantation
Echocardiography
Short Form Survey SF-12 QoL
New York Heart Association NYHA Functional Classification
Re Hospitalization
Bleeding
Myocardial Infarction
Length of index hospital stay
Conversion to open surgery
Unplanned use of mechanical circulatory support CPB , ECMO, transcatheter pumps or
IABP
Cardiac structural complications
Aortic bioprosthetic valve dysfunction
Bioprosthetic valve deterioration
Implantation of multiple ( Less than 1) transcatheter valves during the index hospitalization
Valve malposition
Technical success
Device success
Valve related long term clinical efficacy |
Baseline, Discharge, 30 days, 1 year, 3 year and 5 year |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This is a prospective multicentre singlearm real world post market study designed to evaluate the safety and performance of the Myval Inception Transcatheter Heart Valve THV System in patients with symptomatic severe native aortic stenosis. The study aims to enroll approximately 200 patients across 20 sites in India. The primary objective is to assess early safety at 30 days and clinical efficacy at 1 year based on VARC 3 criteria. Patients will undergo valve implantation via the transfemoral approach and be followed up clinically and telephonically for up to 5 years. The study focuses on generating long term real world evidence for the Myval Inception THV system to support its use in clinical practice. |