NCT01810679

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
355

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

21 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
19 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

2.8 years

First QC Date

March 7, 2013

Last Update Submit

November 15, 2016

Conditions

Aortic Valve StenosisAortic Valve Stenosis With InsufficiencyRegurgitation, Aortic ValveAortic Valve Incompetence

Keywords

aortic valve replacementaortic stenosisaortic steno-insufficiencyPercevalSutureless aortic heart valve

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    One-year

Secondary Outcomes (3)

  • Secondary Efficacy Outcomes

    One-year

  • Secondary Efficacy Outcomes

    One-year

  • Secondary Efficacy Outcomes

    One-year

Other Outcomes (1)

  • Supplementary Analyses

    Discharge

Study Arms (1)

Perceval S Aortic Heart Valve

EXPERIMENTAL

Treatment with the Perceval S Aortic Heart Valve

Device: Perceval S Aortic Heart Valve

Interventions

Perceval S Aortic Heart ValveDEVICE

Perceval S Sutureless Aortic Heart Valve

Perceval S Aortic Heart Valve

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

East Alabama Medical Center

Opelika, Alabama, 36801, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

St. Vincent's Medical Center

Jacksonville, Florida, 32204, United States

Location

Baptist Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

Emory University

Atlanta, Georgia, 30308, United States

Location

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46290, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Oakwood Hospital

Dearborn, Michigan, 48124, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

New York Presbyterian - Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Montefiore Medical Center/Albert Einstein College of Medicine

New York, New York, 10467, United States

Location

Lenox Hill/NS-LIJ

New York, New York, 11075, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Cardiothoracic and Vascluar Surgeons

Austin, Texas, 78756, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Inova Heart and Vascular Institute

Falls Church, Virginia, 22042, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Aortic Valve StenosisAortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Rakesh Suri, MD, DPhil

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2013

First Posted

March 13, 2013

Study Start

April 1, 2013

Primary Completion

February 1, 2016

Study Completion

April 1, 2018

Last Updated

November 16, 2016

Record last verified: 2016-11

Locations

US(21)