Valvular Heart Disease Clinical Trial
Official title:
An Observational, Prospective Evaluation of the SJM Epic Valve
This study is a multi-center, prospective, non-randomized, observational study. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic valve.
This study is a multi-centered, multi-country, prospective, non-randomized, observational
study, without concurrent or matched controls, conducted under a common protocol. Bayesian
methods will be used for the design and analysis of this study. The Bayesian model will
determine if the data for the valve configurations are poolable. Bayesian methods also
provide a means of determining the appropriate stopping time for the study based on the
amount of information generated. The objectives of this study are to confirm the clinical
safety and efficacy of the SJM Epic Valve by establishing the following:
- adverse effect rates
- clinical status as indicated by NYHA functional classification
- hemodynamic performance
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
| Completed |
NCT02241109 -
Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity
|
N/A | |
| Completed |
NCT03799133 -
Safety and Efficacy of the Gastric Reactance (XL) in Patients Post-operated of Elective Cardiac Surgery
|
N/A | |
| Completed |
NCT01676727 -
ADVANCE Direct Aortic Study
|
||
| Completed |
NCT01476995 -
Prognostic Indicators as Provided by the EPIC ClearView
|
N/A | |
| Completed |
NCT00721136 -
Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation
|
N/A | |
| Recruiting |
NCT05014750 -
Frailty of Elderly With Valvular Heart Disease and the Short Term Adverse Events
|
||
| Recruiting |
NCT05044338 -
Study on Standard Evaluation System and Optimal Treatment Path of Senile Valvular Heart Disease
|
||
| Recruiting |
NCT05015829 -
Diagnostic Impact of Low-dose Dobutamine Echocardiography in Low-flow Low-gradient Aortic Stenosis
|
||
| Recruiting |
NCT05078619 -
Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation
|
N/A | |
| Recruiting |
NCT06307262 -
European Registry of Transcatheter Repair for Tricuspid Regurgitation
|
||
| Completed |
NCT01624870 -
CoreValve Advance-II Study: Prospective International Post-market Study
|
||
| Completed |
NCT05708690 -
Topical Effect of Tranexamic Acid in Postoperative Bleeding and Blood Products Transfusion After Cardiac Surgery
|
Phase 4 | |
| Recruiting |
NCT03797820 -
Multicenter Registry Study of Aortic Valve Stenosis in Zhejiang Elderly（Mrs AVS）
|
||
| Recruiting |
NCT06077721 -
Milrinone on Right Ventricular Strain in Cardiac Surgery
|
||
| Not yet recruiting |
NCT04632914 -
Effect of Trunk Stabilizing Exercises on Patients With Median Sternotomy After Heart Valve Surgery
|
N/A | |
| Completed |
NCT01477151 -
Randomized Isoflurane and Sevoflurane Comparison in Cardiac Surgery
|
Phase 4 | |
| Terminated |
NCT03590730 -
Benefits of ICD for the Primary Prevention in Patients With Valvular Cardiomyopathy
|
||
| Recruiting |
NCT06204783 -
Real-time Pressure Volume Loop Monitoring as a Guide for Enhanced Understanding of Changes in Elemental Cardiovascular Physiology During Therapeutic Strategies Aiming for Hemodynamic Optimization. Cohort II: Structural Heart Interventions (PLUTO-II)
|
||
| Enrolling by invitation |
NCT05775354 -
Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project
|
N/A |