Aortic Valve StenosisNCT01810679
Perceval S Aortic Heart Valve Study- North America
A study testing Perceval S Aortic Heart Valve in people with Aortic Valve Stenosis and Aortic Valve Stenosis With Insufficiency, run by Sorin Group USA, Inc. at 21 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve
- What is being tested?
- Perceval S Aortic Heart Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 21 sitesUnited States
- Study dates
- Apr 2013to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Emory University
Atlanta, Georgia, 30308
University of Colorado Denver
Aurora, Colorado, 80045
Cardiothoracic and Vascluar Surgeons
Austin, Texas, 78756
University of Maryland
Baltimore, Maryland, 21201
University of Virginia
Charlottesville, Virginia, 22908
Cleveland Clinic
Cleveland, Ohio, 44195
Oakwood Hospital
Dearborn, Michigan, 48124
Inova Heart and Vascular Institute
Falls Church, Virginia, 22042
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290
St. Vincent's Medical Center
Jacksonville, Florida, 32204
Baptist Cardiac and Vascular Institute
Miami, Florida, 33176
New York Presbyterian - Weill Cornell Medical Center
New York, New York, 10065
Montefiore Medical Center/Albert Einstein College of Medicine
New York, New York, 10467
Lenox Hill/NS-LIJ
New York, New York, 11075
East Alabama Medical Center
Opelika, Alabama, 36801
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Maine Medical Center
Portland, Maine, 04102
Mayo Clinic
Rochester, Minnesota, 55905
University of Washington
Seattle, Washington, 98195
ProMedica Toledo Hospital
Toledo, Ohio, 43606
University of Arizona
Tucson, Arizona, 85724
About this study
Official title: 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.
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.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
- Being tested
- Perceval S Aortic Heart Valve
- Keywords
- aortic valve replacement, aortic stenosis, aortic steno-insufficiency, Perceval, Sutureless aortic heart valve
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perceval S Aortic Heart ValveDevice
Perceval S Sutureless Aortic Heart Valve
| Study group | Role | What they receive |
|---|---|---|
| Perceval S Aortic Heart Valve | Experimental | Treatment with the Perceval S Aortic Heart Valve Receives: Device: Perceval S Aortic Heart Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One-year
Primary Efficacy Endpoint
To demonstrate that the rate of valve success for the PERCEVAL S valve is comparable to that of appropriate historical controls
Measured: One-year
Secondary outcomes (3)
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
Measured: One-year
Secondary Efficacy Outcomes
To demonstrate clinically significant improvements in overall patient condition by comparison of preoperative and postoperative NYHA functional classifications
Measured: One-year
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
Measured: One-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2016
- Study completionApr 2018 (estimated)
Why it stopped: FDA approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorin Group USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rakesh Suri, MD, DPhil, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810679
- Sponsor's protocol ID
- G120053
- Status last verified
- Nov 2016
- First submitted
- 7 Mar 2013
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Perceval S Sutureless Heart Valve
- ClinicalTrials.gov ID
- NCT01810679
- Acronym / sponsor ID
- G120053
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA approval
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Sorin Group USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2018 (estimated)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perceval S Aortic Heart Valve | Experimental | Device: Perceval S Aortic Heart ValveTreatment with the Perceval S Aortic Heart Valve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perceval S Aortic Heart ValvePerceval S Sutureless Aortic Heart Valve | Device | Perceval S Aortic Heart Valve |
Primary outcome
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
3 secondary outcomes
Secondary Efficacy Outcomes
Time frame: One-year
Secondary Efficacy Outcomes
Time frame: One-year
Secondary Efficacy Outcomes
Time frame: One-year
Results and safety
The study was stopped early (reason given: FDA approval). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
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Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rakesh Suri, MD, DPhil principal investigator
The Cleveland Clinic
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perceval S Aortic Heart Valve in people with Aortic Valve Stenosis and Aortic Valve Stenosis With Insufficiency, run by Sorin Group USA, Inc. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: FDA approval). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: One-year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2016; AzTrials last refreshed its copy on 2 Nov 2026.