ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000
This study is ongoing, but not recruiting participants.
Sponsor:
Medtronic Cardiovascular
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT01116024
First received: April 8, 2010
Last updated: February 14, 2012
Last verified: February 2012
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Purpose
This is a prospective, non-randomized, multi-center study designed to evaluate safety and effectiveness of the ATS 3f Enable Aortic Bioprosthesis in a patient population undergoing isolated aortic valve replacement with or without concomitant procedures. The Enable Aortic Valve is an equine pericardial stented bioprosthesis.
| Condition | Intervention |
|---|---|
|
Heart Valve Diseases |
Device: ATS 3f Enable Aortic Bioprosthesis Model 6000 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000 |
Resource links provided by NLM:
Further study details as provided by Medtronic Cardiovascular:
Primary Outcome Measures:
- Migration [ Time Frame: One Year ] [ Designated as safety issue: Yes ]Migration is defined as complete or partial displacement (tilting) of the device from its original locus resulting in coronary ostia blockage, perivalvular leak, or incompetence.
- Thromboembolism/Thrombosis [ Time Frame: One Year ] [ Designated as safety issue: Yes ]Valve related thromboembolism and valvular thrombosis.
- Hemorrhage (all and major) [ Time Frame: One Year ] [ Designated as safety issue: Yes ]All bleeding events regardless of whether or not the event is related to anticoagulation therapy and will be categorized as minor and major events.
- Perivalvular Leaks (all and major) [ Time Frame: One Year ] [ Designated as safety issue: Yes ]All perivalvular leak events will be reported.
- Endocarditis [ Time Frame: One Year ] [ Designated as safety issue: Yes ]Study valve endocarditis.
- Hemolysis [ Time Frame: One Year ] [ Designated as safety issue: Yes ]Hematology/Chemistry data will be analyzed to determine if significant subclinical or unreported hemolysis is occuring.
- Structural Valve Deterioration [ Time Frame: One Year ] [ Designated as safety issue: Yes ]Structural valve deterioration data will be collected.
- Non-Structural Dysfunction [ Time Frame: One Year ] [ Designated as safety issue: Yes ]Perivalvular Leak, Hemolysis, Entrapment by pannus, tissue or suture, Inappropriate sizing or positioning, and Distortion.
- Re-operation, Explant, Death (all Deaths and valve related) [ Time Frame: One Year ] [ Designated as safety issue: Yes ]Re-operations, Explant, and Death (all Deaths and valve related)
Secondary Outcome Measures:
- Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance [ Time Frame: One Year ] [ Designated as safety issue: No ]NYHA classification to asses improvement of the cardiac status, Hemodynamic Performance analysis based on Doppler echocardiographic studies.
| Enrollment: | 173 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | August 2014 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ATS 3f Enable Aortic Bioprosthesis Model 6000 |
Device: ATS 3f Enable Aortic Bioprosthesis Model 6000
Replacement Aortic Heart Valve
|
Detailed Description:
The ATS 3f Enable Aortic Bioprosthesis is intended for those patients whose prognosis without surgical replacement of the diseased natural valve is unacceptably poor in terms of survival and/or quality of life in the opinion of the attending physicians. For these patients, there are a number of widely accepted prosthetic heart valves in use.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- The patient requires isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve repair. (The three remaining valves must be of native tissue).
- The patient is geographically stable and willing to return to the implant site for follow-up visits.
- The patient has been adequately informed of risks and requirements and consent to his/her participation in the clinical study.
- If this patient is female and of childbearing potential, patient has a negative pregnancy test within seven (7) days prior to the study procedure.
Exclusion Criteria:
- The patient requires replacement of two or more valves.
- The patient is < 20 years of age.
- The patient has a non-cardiac major or progressive disease, which in the Investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 24 months.
- The patient is an intravenous drug and/or alcohol abuser.
- The patient presents with active endocarditis or other systemic infection.
- The patient has had previous valve replacement surgery, including previous implant and then explant of the ATS 3f Enable Aortic Bioprosthesis (Model 6000) or placement of a rigid annuloplasty ring in the mitral position.
- The patient is participating in concomitant research studies of investigational products.
- The patient presents with dilatation of the ascending aorta, Marfan Syndrome, Ehlers-Danlos syndrome, cystic medial degeneration, or other condition causing the ascending aorta to be irregular in geometry or physiology as seen via preoperative imaging.
- The patient has chronic renal failure.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116024
Locations
| Austria | |
| Medical University of Vienna | |
| Vienna, Austria | |
| Germany | |
| Johann Wolfgang Goethe University | |
| Frankfurt, Germany | |
| University Medical Center Freiburg | |
| Freiburg, Germany | |
| University Medical Center Kiel | |
| Kiel, Germany | |
| UKSH, Campus Lubeck | |
| Lubeck, Germany | |
| Poland | |
| Medical University of Gdansk | |
| Gdansk, Poland | |
| Jagiellonian University | |
| Krakow, Poland | |
| Switzerland | |
| Cardiac Surgery University Hospital Basel | |
| Basel, Switzerland | |
| Inselspital Bern | |
| Bern, Switzerland | |
| United Kingdom | |
| John Radcliffe Hospital | |
| Oxford, United Kingdom | |
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
| Study Director: | Eric Vang | Medtronic |
More Information
Additional Information:
No publications provided
| Responsible Party: | Medtronic Cardiovascular |
| ClinicalTrials.gov Identifier: | NCT01116024 History of Changes |
| Other Study ID Numbers: | S2005 Rev. 17-MAY-2007 |
| Study First Received: | April 8, 2010 |
| Last Updated: | February 14, 2012 |
| Health Authority: | Austria: Federal Ministry for Health Family and Youth Germany: Paul-Ehrlich-Institut Poland: Ministry of Health Switzerland: Swissmedic United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Medtronic Cardiovascular:
|
Diseased Heart Valve, Replacement, Aortic |
Additional relevant MeSH terms:
|
Heart Valve Diseases Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013