FindTrial
Sign In

AORTIC VALVE NEOCUSPIDISATION VERSUS AORTIC VALVE REPLACEMENT WITH AORTIC VALVE PROSTHESIS- A NON INFERIORITY TRIAL

COMPARATIVE STUDY OF AORTIC VALVE NEOCUSPIDISATION VERSUS AORTIC VALVE REPLACEMENT WITH AORTIC VALVE PROSTHESIS- A NON INFERIORITY TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053754
Enrollment
80
Registered
2023-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: I359- Nonrheumatic aortic valve disorder, unspecified Health Condition 2: I069- Rheumatic aortic valve disease, unspecified

Interventions

Intervention1: AORTIC VALVE NEOCUSPIDISATION: Under general anaesthesia , median sternotomy will be done. Pericardium will be harvested. Preparation of autologous pericardium will be initiated by clea

Sponsors

Dr Reena Jagadeesha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients who will undergo AV Neo cuspidisation for aortic valve disease and AV Replacement either by mechanical/ bioprosthetic valve

Exclusion criteria

Exclusion criteria: 1)Patients undergoing concominant procedure like cabg/other valve surgery along with aortic valve surgery. 2) Patients who do not give consent for participation in the study

Design outcomes

Primary

MeasureTime frame
Mean & peak gradient across AV prosthesis & AV Neo group using Transthoracic 2d echocardiography.Timepoint: 1month & 6months—

Secondary

MeasureTime frame
incidence of complications like recurrence of AR/ AS, infective endocarditis, suture dehiscence, paravalvular leak or stuck valve /root abscess in both groups during follow up periodTimepoint: 1month & 6months;Post operative complications & duration of ICU stayTimepoint: 1month & 6months;The NYHA grade of symptomsTimepoint: 1month & 6months—

Countries

India

Contacts

Public ContactDr Reena Jagadeesha

Postgraduate Institute of Medical Education and Research

dr.anandmishra2015@gmail.com9417567346

Outcome results

None listed

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