Aortic Valve Replacement With Trifecta(TM)

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00475267
• Collaborator: (none)
• Enrollment: 203
• Locations: 5
• Duration (Months): 56
• Patients Per Site: 40.6
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Insufficiency; Regurgitation, Aortic Valve; Aortic Valve Incompetence; Aortic Valve Stenosis	Device: Trifecta aortic heart valve	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 203 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Observational, Prospective Evaluation of the Trifecta Valve
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jan 1, 2012

Outcome Measures

Primary Outcome Measures

1. Characterize patient NYHA functional classification status. [At required follow-up intervals]

2. Characterize the hemodynamic performance of the valve. [At required follow-up intervals]

3. Establish adverse event rates. [Ongoing]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of British Columbia, St. Paul's Hospital	Vancouver	British Columbia	Canada	V6Z 1Y6
2	QEII Health Sciences Center	Halifax	Nova Scotia	Canada	B3H 3A7
3	University Health Network - Toronto General Hospital	Toronto	Ontario	Canada	M5G 2C4
4	Montreal Heart Institute	Montreal	Quebec	Canada	H1T 1C8
5	Hôpital Laval	Québec	Quebec	Canada	GN 4G5

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Hartzell Schaff, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00475267
• Other Study ID Numbers: CS0601
• First Posted: May 21, 2007
• Last Update Posted: Feb 4, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by Abbott Medical Devices: aortic valve; heart valve; tissue valve; bioprosthesis; valve disorder; valve disease; cardiac surgery; aortic valve stenosis; aortic valve regurgitation
• Additional relevant MeSH terms: Aortic Valve Stenosis; Aortic Valve Insufficiency

Study Results

No Results Posted as of Feb 4, 2019