FindTrial
Sign In

Long term survival and complications in patients operated for Prosthetic heart valves on Nicoumalone(Acenocoumarol) and tissue valve outcomes

A Retrospective, Single Center, Observational Study to Evaluate Long-term survival of patients with valvular heart who underwent prosthetic valve replacement and were managed with Nicoumalone (Acenocoumarol) and tissue valve outcomes operated by a single surgeon - ACNL-L21-0104

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/01/039268
Enrollment
718
Registered
2022-01-10
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: I719- Aortic aneurysm of unspecified site, without rupture Health Condition 2: Q874- Marfans syndrome Health Condition 3: I348- Other nonrheumatic mitral valve disorders Health Condition 4: I06- Rheumatic aortic valve diseases Health Condition 5: I05- Rheumatic mitral valve diseases Health Condition 6: I089- Rheumatic multiple valve disease,unspecified Health Condition 7: I07- Rheumatic tricuspid valve diseases

Interventions

None listed

Sponsors

Abbott Healthcare Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient who underwent prosthetic valve replacement since Jan 1971 2. Patient who were managed by Nicoumalone (Acenocoumarol) after the prosthetic valve replacement and whose dose titration was done based on the INR monitoring 3. Patient with no prior history of MACCE- Stroke, MI, and major bleeding

Exclusion criteria

Exclusion criteria: 1. Patient who underwent Cardiac Surgery other than Prosthetic Valve Replacement, eg. Coronary Artery Bypass Graft Surgery(CABG) etc. 2. Patient who underwent prosthetic valve replacement procedure before Jan 1971

Design outcomes

Primary

MeasureTime frame
To measure the overall survival of patients with VHD who underwent prosthetic valve replacement and managed with INR-based dose titration of Nicoumalone (Acenocoumarol)Timepoint: At the end of the follow-up—

Secondary

MeasureTime frame
1. To assess the incidence of major complications associated with the disease like major adverse cardiac and cerebrovascular events (MACCE e.g., Stroke, MI) and major bleeding 2. To assess clinical outcome after surgery for Atrial Fibrillation with Mitral Valve pathology 3. To assess long time survival and clinical outcomes in patients who underwent aortic root enlargement with Aortic Valve surgery 4. To measure clinical outcome after Redo Cardiac surgery 5. To measure association between INR and Stroke or Valve Thrombosis Timepoint: At the end of the follow-up—

Countries

India

Contacts

Public ContactDr D S Saksena

Bombay Hospital and Medical Research Centre, Mumbai

devsaksena@gmail.com

Outcome results

None listed

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