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

NCT01171625 | Completed Results FDA Device

• 1 other identifier: 2007-08
• Study Type: interventional
• Target: 283
• Locations: 6 countries
• Sites: 13

Brief Summary

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.

Conditions

Coronary Artery Disease; Aortic Valve Disorder; Heart Failure; Aortic Valve Stenosis; Aortic Valve Insufficiency

Keywords

PERIMOUNT, Aortic valve replacement/regurgitation

Outcome Measures

Primary Outcomes (3)

• Subject's Percentage of Long Term Safety Performance

  Long term safety performance will be evaluated by comparing the linearized yearly rates to the objective performance criteria (OPC) referenced in the Food and Drug Administration (FDA) 1994 Draft Heart Valve Guidance. Expressed as the Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).

  31 days through 8 years post-implant

• Number of Subject's in NYHA Functional Class I or II at 8 Year Post-Implant

  The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

  8 years post-implant

• Subject's New York Heart Association (NYHA) Functional Class at 8 Years Post-Implant Compared to Baseline

  The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

  8 Years post-implant

Secondary Outcomes (20)

• Percent of Early Adverse Events

  Events occurring within 30 days of procedure

• Percentage of Late Adverse Events

  Events occurring >= 31 days and up through 8 years post-implant

• Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days

  1 Year, 2 Years, 3 Years, 4 Years, 5 Years, 6 Years, 7 Years, and 8 Years post-implant

• Subject's Average Peak Systolic Gradient (mmHg) Measurements at 8 Years Post-implant

  8 years post-implant

• Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant.

  8 years post-implant

Study Arms (1)

CEP Aortic Bioprothesis, model 3300TFX

OTHER

Device: Implantation of CEP Magna Ease Model 3300TFX

Interventions

Implantation of CEP Magna Ease Model 3300TFX DEVICE

Heart Valve Surgery

Also known as: CEP Magna Ease MOdel 3300TFX

CEP Aortic Bioprothesis, model 3300TFX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient requires, as indicated in the preoperative evaluation, a replacement aortic valve.
• The patient is an average or better operative risk.
• The patient is geographically stable and agrees to attend follow-up assessments at the hospital of surgical services for at least 8 years.
• The patient is 18 years or older.
• The patient has signed and dated the subject informed consent form prior to surgery.

You may not qualify if:

• The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year.
• The patient presents with active endocarditis within the last 3 months.
• The patient has an abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism).
• The patient has an aneurismal aortic degenerative condition (e.g., cystic medial necrosis, Marfan's syndrome).
• The patient is pregnant or lactating.
• The patient is an intravenous drug abuser.
• The patient is currently a prison inmate.
• The patient is currently participating in a study of an investigational drug or device.
• The patient requires replacement of a native or prosthetic mitral, tricuspid or pulmonic valve.
• The patient requires a repair of the mitral or tricuspid valve with the use of an annuloplasty device.
• The patient was previously enrolled in the study.
• The patient had a prior mitral, tricuspid or pulmonic valve surgery, which included implantation of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ.

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (13)

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 09762, United States

Location

Providence Heart & Vascular Institute

Portland, Oregon, 97225, United States

Location

St. Marks Hospital

Salt Lake City, Utah, 84124, United States

Location

Universitatslinik fur Chirurgie

Innsbruck, 6020, Austria

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Paul's Hospital

Vancouver, V6Z 1Y6, Canada

Location

Liknik fur Herz und BefaBchirurgie Im Deuschen Herzzentrum

Munich, Lazarettstr, 36, Germany

Location

Klinik fur Herz-, Thorax-, Transplantations- und Gefabchirurgie

Hanover, D-30625, Germany

Location

Hospital Peutra de Hierro

San Martin de Porres 4, Madrid, CP-28035, Spain

Location

Papworth Hospital NHS foundation Trust

Papworth Everard, Cambridge, CV23 3RE, United Kingdom

Location

Blackpool Victoria Hospital

Blackpool, Lancashire, FY8 8NR, United Kingdom

Location

Related Publications (1)

• Wahlers TCW, Andreas M, Rahmanian P, Candolfi P, Zemanova B, Giot C, Ferrari E, Laufer G. Outcomes of a Rapid Deployment Aortic Valve Versus Its Conventional Counterpart: A Propensity-Matched Analysis. Innovations (Phila). 2018 May/Jun;13(3):177-183. doi: 10.1097/IMI.0000000000000509.

  PMID: 29912142 RESULT

Related Links

• New York Heart Association Classification

MeSH Terms

Conditions

Coronary Artery Disease; Aortic Valve Disease; Heart Failure; Aortic Valve Stenosis; Aortic Valve Insufficiency; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Andrey Nersesov, Sr. Director of Clinical Affairs, Surgical Structural Heart
• Organization: Edwards Lifesciences, LLC

Andrey_Nersesov@edwards.com

949-250-2500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: July 26, 2010
• First Posted: July 28, 2010
• Study Start: October 1, 2007
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: April 17, 2020
• Results First Posted: April 17, 2020

Record last verified: 2020-04

Locations

US (5); CA (2); DE (2); ES (1); GB (2); AU (1)