Aortic Valve Stenosis Clinical Trial
Official title:
Randomized Control Study of Anticoagulation With Warfarin Por Patients With Aortic Bioprosthesis vs Aspirin Only
Verified date | February 2022 |
Source | Instituto Nacional de Cirugia Cardiaca, Uruguay |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the clinical and hemodynamic outcome in patients after aortic valve replacement. Half of the patients will receive warfarin + aspirin and the other half will receive only aspirin. The investigators will focus mainly on early bioprosthesis degeneration.
Status | Completed |
Enrollment | 140 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with indication of aortic valve replacement with porcine bioprosthesis Exclusion Criteria: - Concomitant mitral valve replacement - Previous atrial fibrillation - Previous use oral anticoagulation - Contraindication for the use of oral anticoagulation (high risk of bleeding, intolerance, allergy) - Jehovah witness - Platelet count below 90,000. - Liver disease |
Country | Name | City | State |
---|---|---|---|
Uruguay | Centro Cardiovascular Universitario | Montevideo | |
Uruguay | Instituto Nacional de Cirugia Cardiaca | Montevideo |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Cirugia Cardiaca, Uruguay | Universidad de la Republica |
Uruguay,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Transprosthetic aortic gradient | Change in Transprosthetic mean gradient | 3 months and 1 year | |
Primary | Change in New York Heart Association (NYHA) class | NYHA class | 1 year | |
Secondary | Major bleeding | number of patients admitted due to Genitourinary (GU) or Gastrointestinal (GI) bleeding, pericardial tamponade, pleural effusion | 3 months and 1 year | |
Secondary | Embolic events | Number of patients with cerebral and peripheral ischemic events | 3 months and 1 year | |
Secondary | Prosthetic leak | Change in severity of prosthetic and paraprosthetic leakage | 3 months and 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03186339 -
Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
|
||
Recruiting |
NCT03549559 -
Imaging Histone Deacetylase in the Heart
|
N/A | |
Terminated |
NCT02854319 -
REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System
|
N/A | |
Recruiting |
NCT05601453 -
The ReTAVI Prospective Observational Registry
|
||
Withdrawn |
NCT05481814 -
CPX in Paradoxical Low Flow Aortic Stenosis
|
||
Completed |
NCT02241109 -
Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity
|
N/A | |
Completed |
NCT01700439 -
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
|
N/A | |
Recruiting |
NCT04429035 -
SLOW-Slower Progress of caLcificatiOn With Vitamin K2
|
N/A | |
Completed |
NCT04103931 -
Impact of a Patient Decision Aid for Treatment of Aortic Stenosis
|
N/A | |
Completed |
NCT03950440 -
Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
|
||
Active, not recruiting |
NCT02661451 -
Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)
|
N/A | |
Completed |
NCT02847546 -
Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation
|
N/A | |
Completed |
NCT02792452 -
Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
|
||
Completed |
NCT02758964 -
Evaluation of Cerebral Thrombembolism After TAVR
|
||
Not yet recruiting |
NCT02536703 -
Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population
|
Phase 3 | |
Not yet recruiting |
NCT02541877 -
Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve
|
Phase 3 | |
Completed |
NCT02249000 -
BIOVALVE - I / II Clincial Investigation
|
N/A | |
Not yet recruiting |
NCT02221921 -
Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI
|
N/A | |
Active, not recruiting |
NCT02080299 -
Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation
|
Phase 2 | |
Terminated |
NCT01939678 -
Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease
|