Perceval S Aortic Heart Valve Study- North America
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ClinicalTrials.gov Identifier: NCT01810679 |
Recruitment Status
:
Terminated
(FDA approval)
First Posted
: March 13, 2013
Last Update Posted
: November 16, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Aortic Valve Stenosis Aortic Valve Stenosis With Insufficiency Regurgitation, Aortic Valve Aortic Valve Incompetence | Device: Perceval S Aortic Heart Valve | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 355 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Clinical Investigation of the Perceval S Sutureless Heart Valve |
Study Start Date : | April 2013 |
Actual Primary Completion Date : | February 2016 |
Estimated Study Completion Date : | April 2018 |

Arm | Intervention/treatment |
---|---|
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
|
- Primary Safety Endpoint [ Time Frame: One-year ]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 ]To demonstrate that the rate of valve success for the PERCEVAL S valve is comparable to that of appropriate historical controls
- Secondary Efficacy Outcomes [ Time Frame: One-year ]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 ]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 ]To demonstrate that the rate of device technical success for the PERCEVAL S valve is comparable to that of appropriate historical controls
- Supplementary Analyses [ Time Frame: Discharge ]Rates of cross-clamp time, cardiopulmonary bypass time, length of stay in ICU, length of hospital, and quality of life

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810679

Principal Investigator: | Rakesh Suri, MD, DPhil | The Cleveland Clinic |
Responsible Party: | Sorin Group USA, Inc. |
ClinicalTrials.gov Identifier: | NCT01810679 History of Changes |
Other Study ID Numbers: |
G120053 |
First Posted: | March 13, 2013 Key Record Dates |
Last Update Posted: | November 16, 2016 |
Last Verified: | November 2016 |
Keywords provided by Sorin Group USA, Inc.:
aortic valve replacement aortic stenosis aortic steno-insufficiency Perceval Sutureless aortic heart valve |
Additional relevant MeSH terms:
Constriction, Pathologic Aortic Valve Stenosis Aortic Valve Insufficiency Pathological Conditions, Anatomical |
Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction |