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Perceval S Aortic Heart Valve Study- North America

Primary Purpose

Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Perceval S Aortic Heart Valve
Sponsored by
Sorin Group USA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring aortic valve replacement, aortic stenosis, aortic steno-insufficiency, Perceval, Sutureless aortic heart valve

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • East Alabama Medical Center
  • University of Arizona
  • University of Colorado Denver
  • St. Vincent's Medical Center
  • Baptist Cardiac and Vascular Institute
  • Emory University
  • St. Vincent Heart Center of Indiana
  • Maine Medical Center
  • University of Maryland
  • Oakwood Hospital
  • Mayo Clinic
  • New York Presbyterian - Weill Cornell Medical Center
  • Montefiore Medical Center/Albert Einstein College of Medicine
  • Lenox Hill/NS-LIJ
  • Cleveland Clinic
  • ProMedica Toledo Hospital
  • University of Pennsylvania
  • Cardiothoracic and Vascluar Surgeons
  • University of Virginia
  • Inova Heart and Vascular Institute
  • University of Washington

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Perceval S Aortic Heart Valve

Arm Description

Treatment with the Perceval S Aortic Heart Valve

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
March 7, 2013
Last Updated
November 15, 2016
Sponsor
Sorin Group USA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01810679
Brief Title
Perceval S Aortic Heart Valve Study- North America
Official Title
Clinical Investigation of the Perceval S Sutureless Heart Valve
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
FDA approval
Study Start Date
April 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorin Group USA, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
355 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perceval S Aortic Heart Valve
Arm Type
Experimental
Arm Description
Treatment with the Perceval S Aortic Heart Valve
Intervention Type
Device
Intervention Name(s)
Perceval S Aortic Heart Valve
Intervention Description
Perceval S Sutureless Aortic Heart Valve
Primary Outcome Measure Information:
Title
Primary Safety Endpoint
Description
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
Title
Primary Efficacy Endpoint
Description
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 Outcome Measure Information:
Title
Secondary Efficacy Outcomes
Description
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
Title
Secondary Efficacy Outcomes
Description
To demonstrate clinically significant improvements in overall patient condition by comparison of preoperative and postoperative NYHA functional classifications
Time Frame
One-year
Title
Secondary Efficacy Outcomes
Description
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 Pre-specified Outcome Measures:
Title
Supplementary Analyses
Description
Rates of cross-clamp time, cardiopulmonary bypass time, length of stay in ICU, length of hospital, and quality of life
Time Frame
Discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rakesh Suri, MD, DPhil
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Alabama Medical Center
City
Opelika
State/Province
Alabama
ZIP/Postal Code
36801
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
St. Vincent's Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Baptist Cardiac and Vascular Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
St. Vincent Heart Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Oakwood Hospital
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
New York Presbyterian - Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Montefiore Medical Center/Albert Einstein College of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Lenox Hill/NS-LIJ
City
New York
State/Province
New York
ZIP/Postal Code
11075
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
ProMedica Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Cardiothoracic and Vascluar Surgeons
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Heart and Vascular Institute
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

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