Perceval S Aortic Heart Valve Study- North America - Full Text View

Purpose

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.

Condition	Intervention
Aortic Valve Stenosis Aortic Valve Stenosis With Insufficiency Regurgitation, Aortic Valve Aortic Valve Incompetence	Device: Perceval S Aortic Heart Valve


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Clinical Investigation of the Perceval S Sutureless Heart Valve

Resource links provided by NLM:

Genetics Home Reference related topics: supravalvular aortic stenosis

Genetic and Rare Diseases Information Center resources: Aortic Valve Stenosis

U.S. FDA Resources

Further study details as provided by Sorin Group USA, Inc.:

Primary Outcome Measures:

Primary Safety Endpoint [ Time Frame: One-year ] [ Designated as safety issue: Yes ]
To demonstrate that the complication and survival rates for the PERCEVAL S valve are comparable to appropriate historical controls manifested as objective performance criteria (OPCs) and to that reported for other stented bioprostheses in the literature
Primary Efficacy Endpoint [ Time Frame: One-year ] [ Designated as safety issue: No ]
To demonstrate that the rate of valve success for the PERCEVAL S valve is comparable to that of appropriate historical controls

Secondary Outcome Measures:

Secondary Efficacy Outcomes [ Time Frame: One-year ] [ Designated as safety issue: No ]
To demonstrate that the hemodynamic performance of the PERCEVAL S valve is comparable to that reported in the literature for other stented aortic bioprostheses
Secondary Efficacy Outcomes [ Time Frame: One-year ] [ Designated as safety issue: No ]
To demonstrate clinically significant improvements in overall patient condition by comparison of preoperative and postoperative NYHA functional classifications
Secondary Efficacy Outcomes [ Time Frame: One-year ] [ Designated as safety issue: No ]
To demonstrate that the rate of device technical success for the PERCEVAL S valve is comparable to that of appropriate historical controls

Other Outcome Measures:

Supplementary Analyses [ Time Frame: Discharge ] [ Designated as safety issue: No ]
Rates of cross-clamp time, cardiopulmonary bypass time, length of stay in ICU, length of hospital, and quality of life


Estimated Enrollment:	450
Study Start Date:	April 2013
Estimated Study Completion Date:	April 2018
Estimated Primary Completion Date:	January 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Perceval S Aortic Heart Valve Treatment with the Perceval S Aortic Heart Valve	Device: Perceval S Aortic Heart Valve Perceval S Sutureless Aortic Heart Valve

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Subjects of age >= 18 years.
Subjects with aortic valve stenosis or steno-insufficiency.
The subject is willing to sign the informed consent.
The subject in which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement.
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).
Subject will be available to the investigator(s) for postoperative follow-up beyond one year.

Exclusion criteria:

The subject has preexisting valve prosthesis or annuloplasty ring in the mitral, pulmonic or tricuspid position.
The subject requires a double or multiple valve replacement or repair of the mitral, tricuspid, or pulmonic valve.
The subject has a previously implanted PERCEVAL valve that requires replacement.
Subjects requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass.
The subject has active endocarditis.
Subjects with active myocarditis
The subject is or will be participating in a concomitant research study of an investigational product.
Subjects with aneurysmal dilation or dissection of the ascending aortic wall.
The subject is a minor, drug abuser, alcohol abuser, prison inmate, institutionalized, or is unable to give informed consent.
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.
Subjects with known hypersensitivity to nickel alloys.
The subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism.
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.
Subject is known to be noncompliant or is unlikely to complete the study.
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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01810679

Contacts


Contact: Marie T Steinbrink, MA	651-329-0351	marie.steinbrink@sorin.com

Show 22 Study Locations

Sponsors and Collaborators

Sorin Group USA, Inc.

Investigators


Principal Investigator:	Rakesh Suri, MD, DPhil	The Cleveland Clinic

More Information


Responsible Party:	Sorin Group USA, Inc.
ClinicalTrials.gov Identifier:	NCT01810679 History of Changes
Other Study ID Numbers:	G120053
Study First Received:	March 7, 2013
Last Updated:	November 20, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sorin Group USA, Inc.:


aortic valve replacement aortic stenosis aortic steno-insufficiency Perceval Sutureless aortic heart valve

Additional relevant MeSH terms:


Aortic Valve Stenosis Constriction, Pathologic Aortic Valve Insufficiency Heart Defects, Congenital Heart Valve Diseases Pathological Conditions, Anatomical	Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction Cardiovascular Abnormalities Congenital Abnormalities

ClinicalTrials.gov processed this record on September 23, 2016