N/A N=148 Treatment

ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000

Heart Valve Diseases

Bottom Line

View on ClinicalTrials.gov: NCT01116024 ↗

Enrolled (actual)

148

Serious AEs

26.4%

Results posted

Dec 2016

Primary outcome: Primary: Thromboembolism/Thrombosis — 0; 2.7; 2.4; 1.5 percentage of participants/patient-year

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ATS 3f Enable Aortic Bioprosthesis Model 6000 (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Medtronic Cardiovascular
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Thromboembolism/Thrombosis	0; 2.7; 2.4; 1.5; 0	—
PRIMARY Hemorrhage/Bleeding-Anticoagulant/Antiaggregant (All and Major)	1.5; 1.5; 0.9; 0.6	—
PRIMARY Paravalvular Leaks (All and Major)	2.4; 1.5	—
PRIMARY Endocarditis	0.9	—
PRIMARY Hemolysis	2	—
PRIMARY Structural Valve Deterioration	—	—
PRIMARY Non-Structural Dysfunction	2.7	—
PRIMARY Re-operation, Explant, Repair	2.1; 2.1; 0	—
PRIMARY Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance	9; 47; 51; 41; 37; 10	—
PRIMARY Hemodynamic	10.28; 9.02; 8.59; 8.52; 8.77; 8.53	—
PRIMARY Hemodynamics - Effective Orifice Area	1.71; 1.68; 1.70; 1.66; 1.67; 1.62	—
PRIMARY Hemodynamics - Effective Orifice Area Index	0.94; 0.91; 0.93; 0.89; 0.92; 0.89	—

Summary

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01116024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.