Clinical trial NCT01810679: Perceval S Aortic Heart Valve Study- North America
Official title: Clinical Investigation of the Perceval S Sutureless Heart Valve
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Valve Stenosis
Aortic Valve Stenosis With Insufficiency
Regurgitation, Aortic Valve
Aortic Valve Incompetence
Keywords: aortic valve replacement
aortic stenosis
aortic steno-insufficiency
Perceval
Sutureless aortic heart valve
Lead sponsor: Sorin Group USA, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-13
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To demonstrate the safety and effectiveness of the Perceval S heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

Detailed description: This investigation is a prospective, non-randomized, multi-center trial of the PERCEVAL valve implanted in patients requiring aortic valve replacement. The study will be conducted in a maximum of 25 centers in the United States. Patients will be evaluated at each of the following time intervals:preoperative, at implant, in the early postoperative period, in the late postoperative period (between 3 and 6 months postoperatively), at 1 year (between 11 and 13 months postoperatively), and annually until study completion. The duration of the study is anticipated to be 5 years.

Eligibility criteria: Inclusion criteria:

1. Subjects of age \>= 18 years.
2. Subjects with aortic valve stenosis or steno-insufficiency.
3. The subject is willing to sign the informed consent.
4. The subject in which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement.
5. The subject is located in a geographic location that will enable the subject to return to the study site for all follow-up examinations (i.e. geographically stable).
6. Subject will be available to the investigator(s) for postoperative follow-up beyond one year.

Exclusion criteria:

1. The subject has preexisting valve prosthesis or annuloplasty ring in the mitral, pulmonic or tricuspid position.
2. The subject requires a double or multiple valve replacement or repair of the mitral, tricuspid, or pulmonic valve.
3. The subject has a previously implanted PERCEVAL valve that requires replacement.
4. Subjects requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass.
5. The subject has active endocarditis.
6. Subjects with active myocarditis
7. The subject is or will be participating in a concomitant research study of an investigational product.
8. Subjects with aneurysmal dilation or dissection of the ascending aortic wall.
9. The subject is a minor, drug abuser, alcohol abuser, prison inmate, institutionalized, or is unable to give informed consent.
10. The subject has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the patient.
11. Subjects with known hypersensitivity to nickel alloys.
12. The subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism.
13. The subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized ≥30 days prior to the planned valve implant surgery.
14. Subject is known to be noncompliant or is unlikely to complete the study.
15. Subjects with an aortic root enlargement, where the ratio between the diameter of the sino-tubular junction and the annulus diameter, assessed by TTE, is \> 1.3.

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: One-year
measure: Primary Efficacy Endpoint
timeFrame: One-year
Secondary outcomes:
measure: Secondary Efficacy Outcomes
timeFrame: One-year
measure: Secondary Efficacy Outcomes
timeFrame: One-year
measure: Secondary Efficacy Outcomes
timeFrame: One-year
Other outcomes:
measure: Supplementary Analyses
timeFrame: Discharge
Locations:
city: Opelika
country: United States
facility: East Alabama Medical Center
state: Alabama
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Jacksonville
country: United States
facility: St. Vincent's Medical Center
state: Florida
city: Miami
country: United States
facility: Baptist Cardiac and Vascular Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana
state: Indiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Dearborn
country: United States
facility: Oakwood Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: New York Presbyterian - Weill Cornell Medical Center
state: New York
city: New York
country: United States
facility: Montefiore Medical Center/Albert Einstein College of Medicine
state: New York
city: New York
country: United States
facility: Lenox Hill/NS-LIJ
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Austin
country: United States
facility: Cardiothoracic and Vascluar Surgeons
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Falls Church
country: United States
facility: Inova Heart and Vascular Institute
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: The Cleveland Clinic
name: Rakesh Suri, MD, DPhil
role: PRINCIPAL_INVESTIGATOR
References: