Post Market ATS 3f® Aortic Bioprosthesis, Model 1000, Size 19mm

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of the ATS 3f® Aortic Bioprosthesis, Model 1000 (Equine Pericardial Bioprothesis) size 19mm in a patient population undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement of a failed prosthesis.

Clinical Trial Description

A multi-center, post market, non-randomized trial, designed to obtain safety and efficacy data from patients implanted with the size 19mm Model 1000 heart valve. Each enrolled patient will be followed until one year post-implantation. Data will be collected both retrospectively and prospectively, on patients who were implanted from 1-Jan-2009 to 31-Dec-2009 with the 19mm Model 1000. The data collected will be pooled with the data currently collected, under the U.S. Food and Drug Administration (FDA) IDE Number G01284 for submission to the U.S. FDA. ;

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Heart Valve Diseases

Clinical Trial Details

NCT number	NCT01156272
Study type	Observational
Source	Medtronic Cardiovascular
Contact
Status	Withdrawn
Phase	N/A
Start date	June 2010
Completion date	June 2011

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT02865798` - China Senile Valvular Heart Disease Cohort Study	N/A
Completed	`NCT02249000` - BIOVALVE - I / II Clincial Investigation	N/A
Completed	`NCT02297334` - Removal of Cytokines During Extracorporeal Circulation in Cardiac Surgery	N/A
Completed	`NCT01591018` - SONOlysis in Risk REduction of Symptomatic and Silent Brain infarCtions dUring Cardiac surgEry	Phase 3
Completed	`NCT01428947` - Does Coronary Angiography Cause Cognitive Dysfunction?	N/A
Recruiting	`NCT01231776` - Acupuncture Improves Sleep in Patients Undergoing Cardiopulmonary Bypass	N/A
Terminated	`NCT01116037` - ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study	N/A
Completed	`NCT00371891` - Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS)	Phase 4
Terminated	`NCT03632967` - Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System	N/A
Recruiting	`NCT05728047` - Evaluation of Systemic Microcirculation of Patients Undergoing Heart Valve Surgery
Not yet recruiting	`NCT05539261` - Research on Neurological Prognosis of Patients Undergoing Heart Valve Surgery
Completed	`NCT05479968` - Spectroscopic Assessment of Intramyocardial Oxygen Saturation Feasibility During Open-heart Surgery
Completed	`NCT03527381` - Nitric Oxide in Cardiopulmonary Bypass for Renal Protection in Cardiac Surgery	Phase 1/Phase 2
Completed	`NCT03664102` - Automated Fastener Device Versus Manually Tied Knot in MiAVR
Recruiting	`NCT06084091` - Spectroscopic Assessment of Intramyocardial Oxygen Saturation During Open-Heart Surgery
Completed	`NCT05836467` - Is Myocardial Revascularization Really Necessary in Patients With ≥50-70% Coronary Stenosis Undergoing Valvular Surgery?
Recruiting	`NCT05933083` - MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation	N/A
Recruiting	`NCT04445012` - Cardiovascular Acoustics and an Intelligent Stethoscope
Active, not recruiting	`NCT02732691` - JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study	N/A
Completed	`NCT02981953` - TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System	N/A