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A clinical study to check how safe and effective Triumvir, a dry transcatheter aortic valve replacement, is for patients who need a new aortic heart valve.

A prospective, multi-centre, single arm, pivotal clinical study to determine the safety and effectiveness of Triumvir (Dry Transcatheter Aortic Valve Replacement) for use as a Replacement Aortic Heart Valve. - Nil

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080986
Enrollment
15
Registered
2025-02-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

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: Triumvir (Dry Transcatheter Aortic Valve Replacement): Triumvir (Dry Transcatheter Aortic Valve Replacement) Frequency-Once, Duration-Lifetime Control Intervention1: NIL: NIL

Sponsors

Onecrea Medical India Pvt Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female at least 18 years of age. 2. Patient provides written informed consent and agrees to all follow-up visits. 3. Patients life expectancy at least 1 year. 4. subjects with symptomatic heart disease due to severe native calcific aortic stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure who are judged by a heart team, including a cardiac surgeon, to be at high or high risk for open surgical therapy. 5. Patient anatomy is eligible for TAVR treatment with the investigational device per the Indications in the Instructions for Use. 6. Bicuspid aortic valve can be included at the discretion of the Physician team

Exclusion criteria

Exclusion criteria: 1. Patients with Mechanical valve in the aortic position. 2. Known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to contrast media, which cannot be adequately premedicated. 3. Known allergy to any device component. 4. Ongoing sepsis, including active endocarditis 5. Pregnant (female of childbearing potential only). 6. Patient with Ejection Fraction of less than 35%. 7. Patient expected to undergo for coronary intervention within 12 Months

Design outcomes

Primary

MeasureTime frame
Safety Endpoint is evaluated by 1. All-cause mortality 2. Valve-related morbidity [stroke and transient ischemic attack (TIA) 3. Major and minor bleeding 4. Acute kidney injury (AKI) 5. Valve thrombosis. 6. Structural/non-structural valve deterioration or dysfunction 7. Prosthetic valve endocarditis 8. Myocardial infarction 9. Conduction disturbances and arrhythmias 10. Aortic valve apparatus damage or dysfunction 11. Explant 12. Hemolysis Timepoint: baseline, procedure, discharge, 1 month, 3 months, 6 months and 12 months—

Secondary

MeasureTime frame
The Secondary study endpoints are: Device success Procedural success Quality of lifeTimepoint: baseline, procedure, discharge, 1 month, 3 months, 6 months & 12 months—

Countries

India

Contacts

Public ContactDr Ashwini Kumar

G. Kuppuswamy Naidu Memorial Hospital, Coimbatore

rka.trials@gmail.com9443272172

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026