Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01171625
First received: July 26, 2010
Last updated: April 15, 2014
Last verified: October 2012
  Purpose

The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.


Condition Intervention Phase
Coronary Artery Disease
Aortic Valve Disorder
Heart Failure
Aortic Valve Stenosis
Aortic Valve Insufficiency
Device: Implantation of CEP Magna Ease Model 3300TFX
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis in the Aortic Position, Model 3300TFX

Resource links provided by NLM:


Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • Long term safety performance will be evaluated by comparing the linearized yearly rates listed below to the objective performance criteria (OPC) referenced in the Food and Drug Administration (FDA) 1994 Draft Heart Valve Guidance [ Time Frame: Entire study period (8 yrs post implant) ] [ Designated as safety issue: Yes ]
    a) Thromboembolism, b) All Hemorrhage, c) All Perivalvular Leak, d) Endocarditis


Secondary Outcome Measures:
  • Early rates, late linearized rates, and actuarial rates [ Time Frame: Entire study period (8 yrs post implant) ] [ Designated as safety issue: Yes ]
    Early rates, late linearized rates, and actuarial rates of: a) Thromboembolism b) Valve Thrombosis, c) All Hemorrhage, d) Major Hemorrhage, e) All Perivalvular leak, f) Major perivalvular leak, g) Endocarditis, h) Hemolysis, i) Structural valve deterioration, j) Non-structural valve dysfunction, k) Reoperation, l) Explant, m) Death, n) Valve Related death


Estimated Enrollment: 225
Study Start Date: October 2007
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CEP Aortic Bioprothesis, model 3300TFX Device: Implantation of CEP Magna Ease Model 3300TFX
Heart Valve Surgery
Other Name: CEP Magna Ease MOdel 3300TFX

Detailed Description:

This is a prospective, single-arm, multi-center, interventional study to be conducted in the US and outside the US (OUS). This study will enroll a minimum of 225 patients implanted with the study valve in order to achieve 101 aortic valve replacement subjects each followed for a minimum of 8 years. The study will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged or malfunctioning natural or prosthetic aortic valve. Patients will be followed and assessed after implant annually for a minimum of 8 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary
  • Require replacement aortic valve
  • Signed informed consent

Exclusion Criteria:

  • Primary
  • Active endocarditis (< 3 mths)
  • Abnormal Ca metabolism
  • Aneurismal aortic degenerative condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171625

Locations
United States, California
Mercy General Hospital
Sacramento, California, United States, 95819
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Morristown Memorial Hospital
Morristown, New Jersey, United States, 09762
United States, Oregon
Providence Heart & Vascular Institute
Portland, Oregon, United States, 97225
United States, Utah
St. Marks Hospital
Salt Lake City, Utah, United States, 84124
Austria
Universitatslinik fur Chirurgie
Anichstr. 35, Innsbruck, Austria, 6020
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada
St. Paul's Hospital
Vancouver, Canada, V6Z 1Y6
Germany
Liknik fur Herz und BefaBchirurgie Im Deuschen Herzzentrum
Munich, Lazarettstr, Germany, 36
Klinik fur Herz-, Thorax-, Transplantations- und Gefabchirurgie
Hannover, Germany, D-30625
Spain
Hospital Peutra de Hierro
San Martin de Porres 4, Madrid, Spain, CP-28035
United Kingdom
Papworth Hospital NHS foundation Trust
Papworth Everard, Cambridge, United Kingdom, CV23 3RE
Blackpool Victoria Hospital
Blackpool, Lancashire, United Kingdom, FY8 8NR
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Study Director: Bruce Van Deman Edwards Lifesciences
  More Information

No publications provided

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01171625     History of Changes
Other Study ID Numbers: 2007-08
Study First Received: July 26, 2010
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Edwards Lifesciences:
PERIMOUNT, Aortic valve replacement/regurgitation

Additional relevant MeSH terms:
Aortic Valve Insufficiency
Aortic Valve Stenosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Failure
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014