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Myval™ Octacor Transcatheter Heart Valve is indicated for patients with narrowing of heart aortic valve opening. In this condition, valve leaflet loses the ability to open and close, thus weakening the heart for which valve replacement is the only preferred treatment.

Matchball-2: A real-world, retrospective, multi-centre, observational registry to evaluate the safety and performance of Myval™ Octacor in patients with symptomatic severe native aortic valve stenosis. - Matchball-2

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/07/055010
Enrollment
100
Registered
2023-07-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Dr Manik Chopra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All consecutive patients with symptomatic severe native aortic valve stenosis treated with Myval™ Octacor as per Investigator’s discretion in real-world settings.

Exclusion criteria

Exclusion criteria: As this is a retrospective review of data, there are no formal exclusion criteria for the study.

Design outcomes

Primary

MeasureTime frame
It is a composite of the following: 1.All-cause mortality 2.All Stroke 3.Acute Kidney Injury 4.Major vascular complications 5.Moderate or severe paravalvular regurgitation 6.New permanent pacemaker implantationTimepoint: 30 days—

Secondary

MeasureTime frame
1. All-cause mortality 2. All stroke 3. Acute Kidney Injury System-Stage 2 or Stage 3 4. New permanent pacemaker implantation 5. Moderate or severe paravalvular regurgitation 6. Conduction disturbances & Arrythmias 7. Procedure-related or valve-related hospitalization 8. Bleeding complication 9. Vascular & access-related complications 10. Major cardiac structural complications 11. Conversion to open surgery 12. Implantation of multiple transcatheter valves during the index hospitalization 13. Valve malposition 14. Myocardial infarction 15. Bioprosthetic valve dysfunction 16. Functional improvement from baseline as measured per New York Heart Association functional classification 17. Length of index hospital stay 18. Technical success 19. Device success 20. Early safety 21. Freedom from surgery or intervention related to the device (Excluding permanent pacemaker) 22. EchocardiographyTimepoint: Baseline Post-procedure Discharge 30 days—

Countries

India

Contacts

Public ContactDr Manik Chopra

Narayana Multispeciality Hospital

manikchopra2003@gmail.com9316545152

Outcome results

None listed

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