Perceval S Aortic Heart Valve Study- North America

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Sorin Group USA, Inc.
Information provided by (Responsible Party):
Sorin Group USA, Inc. Identifier:
First received: March 7, 2013
Last updated: November 20, 2015
Last verified: November 2015
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:

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  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 identifier: NCT01810679

Contact: Marie T Steinbrink, MA 651-329-0351

  Show 22 Study Locations
Sponsors and Collaborators
Sorin Group USA, Inc.
Principal Investigator: Rakesh Suri, MD, DPhil The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Sorin Group USA, Inc. 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
Sutureless aortic heart valve

Additional relevant MeSH terms:
Aortic Valve Insufficiency
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Diseases
Pathological Conditions, Anatomical
Ventricular Outflow Obstruction processed this record on November 24, 2015