Perceval S Aortic Heart Valve Study- North America

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Sorin Group USA, Inc.
Sponsor:
Information provided by (Responsible Party):
Sorin Group USA, Inc.
ClinicalTrials.gov Identifier:
NCT01810679
First received: March 7, 2013
Last updated: April 14, 2014
Last verified: April 2014

March 7, 2013
April 14, 2014
April 2013
December 2015   (final data collection date for primary outcome measure)
  • 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
Not Provided
Complete list of historical versions of study NCT01810679 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
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
Not Provided
 
Perceval S Aortic Heart Valve Study- North America
Clinical Investigation of the Perceval S Sutureless Heart Valve

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aortic Valve Stenosis
  • Aortic Valve Stenosis With Insufficiency
  • Regurgitation, Aortic Valve
  • Aortic Valve Incompetence
Device: Perceval S Aortic Heart Valve
Perceval S Sutureless Aortic Heart Valve
Experimental: Perceval S Aortic Heart Valve
Treatment with the Perceval S Aortic Heart Valve
Intervention: Device: Perceval S Aortic Heart Valve
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
April 2018
December 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Marie T Steinbrink, MA 651-329-0351 marie.steinbrink@sorin.com
Contact: Sheri L Halverson, MPH 720-369-7633 sheri.halverson@sorin.com
United States
 
NCT01810679
G120053
Yes
Sorin Group USA, Inc.
Sorin Group USA, Inc.
Not Provided
Principal Investigator: Rakesh Suri, MD, DPhil Mayo Clinic- Rochester, MN
Sorin Group USA, Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP