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Perceval S Aortic Heart Valve Study- North America
This study has been terminated.
(FDA approval)
Sponsor:
Sorin Group USA, Inc.
Information provided by (Responsible Party):
Sorin Group USA, Inc.
ClinicalTrials.gov Identifier:
NCT01810679
First received: March 7, 2013
Last updated: November 15, 2016
Last verified: November 2016
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Purpose
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: | 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 ]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 Outcome Measures:
- 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
Other Outcome Measures:
- 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
| Enrollment: | 355 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | April 2018 |
| Primary Completion Date: | February 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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01810679
Show 21 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01810679
Show 21 Study Locations
Sponsors and Collaborators
Sorin Group USA, Inc.
Investigators
| Principal Investigator: | Rakesh Suri, MD, DPhil | The Cleveland Clinic |
More Information
| Responsible Party: | Sorin Group USA, Inc. |
| ClinicalTrials.gov Identifier: | NCT01810679 History of Changes |
| Other Study ID Numbers: |
G120053 |
| Study First Received: | March 7, 2013 |
| Last Updated: | November 15, 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 Heart Defects, Congenital Heart Valve Diseases Pathological Conditions, Anatomical |
Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction Cardiovascular Abnormalities Congenital Abnormalities |
ClinicalTrials.gov processed this record on June 27, 2017