To evaluate the safety and effectiveness of the ATS 3f Enable* Aortic Bioprosthesis equine pericardial stented bioprosthesis in a patient population undergoing isolated aortic valve replacement with or without concomitant procedures.
ID
Source
Brief title
Condition
- Cardiac valve disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary effectiveness endpoints will be determined by the New York Heart
Association (NYHA) functional classification by comparing baseline
(preoperatively) to each postoperative assessment. Additionally, NYHA
functional classification data will be compared to data for other similar
valves (stented bioprosthetic valves) published in articles in the prosthetic
heart valve literature.
Hemodynamic performance of the implanted valve will be evaluated at each
postoperative assessment.
The primary safety endpoints for the study are valve migration, valvular
thrombosis, valve related thromboembolism, hemorrhage (all and major),
perivalvular leak (all and major), endocarditis, hemolysis, structural valve
deterioration, nonstructural dysfunction, reoperation, explant, and death (all
and valve related).
Secondary outcome
Long term safety endpoints will be compared to twice the Objective Performance
Criteria (OPC) events as is standard for prosthetic heart valve studies.
Background summary
ATS Medical Inc. has developed an aortic heart valve (ATS 3f Enable* Aortic
Bioprosthesis) designed to increase patient safety by reducing the duration of
cardiopulmonary bypass and cross-clamp time during surgery, through the
reduction of the time required to implant the valve.
Study objective
To evaluate the safety and effectiveness of the ATS 3f Enable* Aortic
Bioprosthesis equine pericardial stented bioprosthesis in a patient population
undergoing isolated aortic valve replacement with or without concomitant
procedures.
Study design
A prospective, non-randomized, multi-center study designed to evaluate safety
and effectiveness of the device using a common clinical protocol.
Intervention
The ATS 3f Enable* Aortic Bioprosthesis was developed for aortic valve
replacement.
The ENABLE bioprosthesis is supplied sterile. A polyacetal homopolymer folding
sleeve is attached to the bioprosthesis and is used in conjunction with an
accessory inserter system to aid in folding and inserting of the bioprosthesis.
Study burden and risks
General surgical risks may include but are not limited to: anesthesia
complications, drug reactions, infection/inflammation which can lead to
endocarditis, pain and discomfort or bleeding at the incision site or chest
drainage tube insertion site.
The primary risk associated with prosthetic heart valve replacement is failure
to restore heart valve function. All prosthetic heart valve implants carry
risks of serious complications and/or death related to unacceptable
hemodynamics, durability, valvular thrombosis, thromboembolism, hemorrhage,
endocarditis, perivalvular leak, hemolysis, valvular pannus, nonstructural
dysfunction, structural valve deterioration, reoperation, explantation,
arrhythmia, heart failure, angina, myocardial infarction, stroke, and
death.[1] Risks may also include calcification of the prosthetic valve
leaflets and transmission of virus. In addition, risks specific to this ATS 3f
Enable* Aortic Bioprosthesis may include valve migration (movement of the valve
from its original locus), tilting, distortion, stent failure (fracture or
corrosion), or perforation of the aorta due to stent post.
The primary benefit is restoration of heart blood flow control by replacement
of the diseased heart valve. In addition, since the primary implantation of
this valve is limited to a guiding stitch, it is expected that a patient
receiving this device may require shorter exposure to the risks of
cardiopulmonary bypass or Heart/Lung Machine (HLM) than a similar patient
receiving a commercially available bioprosthetic valve.
3905 Annapolis Ln., Ste.105
Plymouth, MN 55447
USA
3905 Annapolis Ln., Ste.105
Plymouth, MN 55447
USA
Listed location countries
Age
Inclusion criteria
Preoperative Inclusion Criteria
1. This 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).
2. This patient is geographically stable and willing to return to the implant site for follow-up visits.
3. This patient has been adequately informed of risks and requirements and consents to his/her participation in the clinical study.
4. 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
Preoperative Exclusion Criteria
1. This patient requires replacement of two or more valves.
2. This patient is < 20 years of age.
3. This 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.
4. This patient is an intravenous drug and/or alcohol abuser.
5. This patient presents with active endocarditis or other systemic infection.
6. This 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.
7. This patient is participating in concomitant research studies of investigational products.
8. This 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.
9. This patient has chronic renal failure. ;Preoperative Exclusion Criterion for Single Guiding Suture Technique
1. Since this protocol stipulates that the study valve must be fully sutured in place (using standard valve suture placement technique) or abandoned at implant if the patient presents with fused or non-fused bicuspid valve or irregular annular geometry, any patient with fused or non-fused bicuspid valve or irregular annular geometry will be excluded if Investigator elects not to fully suture the valve in place. ;Intraoperative Exclusion Criteria
1. This patient presents with abnormal geometry of the coronary ostia, not seen by preoperative imaging, which presents a risk that the study device may occlude one or all ostia.
2. This 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 not seen in preoperative imaging.
3. This patient has or requires treatment with a rigid annuloplasty ring in the mitral position at the time of the procedure.
4. This patient presents with active endocarditis not detected preoperatively.;Intraoperative Exclusion Criteria for Single Guiding Suture Technique
1. This patient presents with fused or non-fused bicuspid valve or irregular annular geometry not seen in preoperative imaging and Investigator elects not to fully suture the valve in place. Note: This protocol allows Investigator to implant the study device using standard valve suture placement in patients with fused or non-fused bicuspid valve or irregular annular geometry.
2. After debriding the annulus, the operating surgeon determines that this patient has residual calcification that would not provide optimal fit for the study device.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | DE/CA25/00004193-00 |
| CCMO | NL22067.100.08 |