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

NCT00475709

CS0501

Details and patient eligibility

About

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: 1,022 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)

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1,022 participants in 1 patient group

Trifecta Aortic Heart Valve

Experimental group

Description:

All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.

Treatment:

Device: Trifecta Aortic Heart Valve