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TerminatedNCT01810679Updated Nov 16, 2016

Perceval S Aortic Heart Valve Study- North America

An interventional study of Perceval S Aortic Heart Valve in Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency and Regurgitation, Aortic Valve, sponsored by Sorin Group USA, Inc.. Terminated at 21 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-16.

Sponsored by Sorin Group USA, Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated
FDA approval
Phase
Not applicable
Study type
Interventional
Enrollment
355
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's enrollment of 355 is above the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Sorin Group USA, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
355 participants (actual)

Study arms

  • Experimental
    Perceval S Aortic Heart Valve

    Treatment with the Perceval S Aortic Heart Valve

    Device: Perceval S Aortic Heart Valve

Interventions

  • DevicePerceval S Aortic Heart Valve

    Perceval S Sutureless Aortic Heart Valve

06

What researchers measure

Primary outcomes

  1. Primary Safety Endpoint

    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

    Time frame: One-year

  2. Primary Efficacy Endpoint

    To demonstrate that the rate of valve success for the PERCEVAL S valve is comparable to that of appropriate historical controls

    Time frame: One-year

Secondary outcomes

  1. Secondary Efficacy Outcomes

    To demonstrate that the hemodynamic performance of the PERCEVAL S valve is comparable to that reported in the literature for other stented aortic bioprostheses

    Time frame: One-year

  2. Secondary Efficacy Outcomes

    To demonstrate clinically significant improvements in overall patient condition by comparison of preoperative and postoperative NYHA functional classifications

    Time frame: One-year

  3. Secondary Efficacy Outcomes

    To demonstrate that the rate of device technical success for the PERCEVAL S valve is comparable to that of appropriate historical controls

    Time frame: One-year

Other outcomes

  1. Supplementary Analyses

    Rates of cross-clamp time, cardiopulmonary bypass time, length of stay in ICU, length of hospital, and quality of life

    Time frame: Discharge

07

Study locations

21 sites
  • East Alabama Medical Center
    Opelika, Alabama 36801, United States
  • University of Arizona
    Tucson, Arizona 85724, United States
  • University of Colorado Denver
    Aurora, Colorado 80045, United States
  • St. Vincent's Medical Center
    Jacksonville, Florida 32204, United States
  • Baptist Cardiac and Vascular Institute
    Miami, Florida 33176, United States
  • Emory University
    Atlanta, Georgia 30308, United States
  • St. Vincent Heart Center of Indiana
    Indianapolis, Indiana 46290, United States
  • Maine Medical Center
    Portland, Maine 04102, United States
  • University of Maryland
    Baltimore, Maryland 21201, United States
  • Oakwood Hospital
    Dearborn, Michigan 48124, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • New York Presbyterian - Weill Cornell Medical Center
    New York, New York 10065, United States
  • Montefiore Medical Center/Albert Einstein College of Medicine
    New York, New York 10467, United States
  • Lenox Hill/NS-LIJ
    New York, New York 11075, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • ProMedica Toledo Hospital
    Toledo, Ohio 43606, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Cardiothoracic and Vascluar Surgeons
    Austin, Texas 78756, United States
  • University of Virginia
    Charlottesville, Virginia 22908, United States
  • Inova Heart and Vascular Institute
    Falls Church, Virginia 22042, United States
  • University of Washington
    Seattle, Washington 98195, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01810679
Lead sponsor
Sorin Group USA, Inc.
Responsible party
Sponsor
First posted
Mar 13, 2013
Start date
Apr 2013
Primary completion
Feb 2016
Completion
Apr 2018 (estimated)
Last update
Nov 16, 2016

Study contacts

Rakesh Suri, MD, DPhil
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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