Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve

Abbott

Status: Completed

Conditions: Heart Valve Diseases

Treatments: Device: Trifecta valve

Study type: Interventional

Funder types: Industry

Identifiers

NCT01514162

1003

Details and patient eligibility

About

To further evaluate the long term clinical safety and effectiveness of the Trifecta valve

Full description

To further evaluate the long term clinical safety and effectiveness of the Trifecta valve in subjects who had a Trifecta valve implanted during the IDE study.

Enrollment: 245 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects implanted with a Trifecta valve at one of the US sites of the IDE study.
• Subject met eligibility criteria of IDE study
• Subject agrees to complete study follow-up visits
• Subject provides written informed consent

Exclusion criteria

• Subject currently participating in another device or drug study
• Subject unable or unwilling to return for study follow-up visits

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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245 participants in 1 patient group

Trifecta Valve Group

Experimental group

Description:

Subjects implanted with a Trifecta valve.

Treatment:

Device: Trifecta valve