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)

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 - NIL

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/08/092397

Enrollment

200

Registered

2025-08-05

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I350- Nonrheumatic aortic (valve) stenosis

Interventions

Intervention1: Myval Inception Transcatheter Heart Valve System: A balloon-expandable transcatheter heart valve system used via transfemoral access to treat symptomatic severe native aortic stenosis.

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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. Timepoint: 30 days and 1 year	—

Measure

Time frame

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. Timepoint: 30 days and 1 year

—

Secondary

Measure	Time frame
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 efficacyTimepoint: Baseline, Discharge, 30 days, 1 year, 3 year and 5 year	—

Measure

Time frame

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 efficacyTimepoint: Baseline, Discharge, 30 days, 1 year, 3 year and 5 year

—

Countries

India

Contacts

Public ContactDr Ashok Thakkar

Meril Life Sciences Pvt. Ltd.

ashok.thakkar@merillife.com912603052100

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026