Aortic Valve Replacement With Trifecta(TM)

Abbott

Status: Completed

Conditions: Regurgitation, Aortic Valve; Aortic Valve Stenosis; Aortic Valve Insufficiency; Aortic Valve Incompetence

Treatments: Device: Trifecta aortic heart valve

Study type: Interventional

Funder types: Industry

Identifiers

NCT00475267

CS0601

Details and patient eligibility

About

The purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta valve.

Full description

The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the Trifecta valve.

Enrollment: 203 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Requires aortic valve replacement (heart surgery such as bypass is allowed at the same time).
• Legal age.
• Signed informed consent prior to surgery.
• Willing to complete all follow-up requirements.

Exclusion criteria

• Pregnant or nursing women.
• Have already had a valve replaced other than the aortic valve.
• Needs another valve replaced.
• Cannot return for required follow-up visits.
• Have active endocarditis.
• Acute preoperative neurological event (such as a stroke).
• Renal dialysis.
• History of substance abuse within one year, or a prison inmate.
• Participating in another study.
• Life expectancy less than two years.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)