Clinical trial NCT01171625: Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX
Official title: Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis in the Aortic Position, Model 3300TFX
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Aortic Valve Disorder
Heart Failure
Aortic Valve Stenosis
Aortic Valve Insufficiency
Keywords: PERIMOUNT, Aortic valve replacement/regurgitation
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2010-07-28
Enrollment: 283
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 at discharge, 6 months, one year, and annually for a minimum of 8 years.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year.
2. The patient presents with active endocarditis within the last 3 months.
3. The patient has an abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism).
4. The patient has an aneurismal aortic degenerative condition (e.g., cystic medial necrosis, Marfan's syndrome).
5. The patient is pregnant or lactating.
6. The patient is an intravenous drug abuser.
7. The patient is currently a prison inmate.
8. The patient is currently participating in a study of an investigational drug or device.
9. The patient requires replacement of a native or prosthetic mitral, tricuspid or pulmonic valve.
10. The patient requires a repair of the mitral or tricuspid valve with the use of an annuloplasty device.
11. The patient was previously enrolled in the study.
12. 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.

Primary outcomes:
measure: Subject's Percentage of Long Term Safety Performance
timeFrame: 31 days through 8 years post-implant
measure: Number of Subject's in NYHA Functional Class I or II at 8 Year Post-Implant
timeFrame: 8 years post-implant
measure: Subject's New York Heart Association (NYHA) Functional Class at 8 Years Post-Implant Compared to Baseline
timeFrame: 8 Years post-implant
Secondary outcomes:
measure: Percent of Early Adverse Events
timeFrame: Events occurring within 30 days of procedure
measure: Percentage of Late Adverse Events
timeFrame: Events occurring >= 31 days and up through 8 years post-implant
measure: Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days
timeFrame: 1 Year, 2 Years, 3 Years, 4 Years, 5 Years, 6 Years, 7 Years, and 8 Years post-implant
measure: Subject's Average Peak Systolic Gradient (mmHg) Measurements at 8 Years Post-implant
timeFrame: 8 years post-implant
measure: Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant.
timeFrame: 8 years post-implant
measure: Subject's Average Effective Orifice Area Measurements at 8 Years Post-implant.
timeFrame: 8 years post-implant
measure: Subject's Average Effective Orifice Area Index (EOAI) Measurements at 8 Years Post-implant.
timeFrame: 8 years post-implant
measure: Subject's Average Performance Index Measurements at 8 Years Post-implant.
timeFrame: 8 years post-implant
measure: Subject's Average Cardiac Output Measurements at 8 Years Post-implant.
timeFrame: 8 years post-implant
measure: Subject's Average Cardiac Index Measurements at 8 Years Post-implant.
timeFrame: 8 years post-implant
measure: Subject's Amount of Aortic Valvular Regurgitation at 8 Years Post-Implant.
timeFrame: 8 years post-implant
measure: Subject's Average White Blood Cell Count Measurement Over Time.
timeFrame: 6 months and annually for 8 years post-implant
measure: Subject's Average Red Blood Cells Count Over Time.
timeFrame: 6 months and annually for 8 years post-implant
measure: Subject's Average Hematocrit Percentage Over Time.
timeFrame: 6 months and annually for 8 years post-implant
measure: Subject's Average Hemoglobin Count Over Time.
timeFrame: 6 months and annually for 8 years post-implant
measure: Subject's Average Platelet Count Over Time.
timeFrame: 6 months and annually for 8 years post-implant
measure: Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time.
timeFrame: 6 months and annually for 8 years post-implant
measure: Subject's Average Haptoglobin Measurement Over Time.
timeFrame: 6 months and annually for 8 years post-implant
measure: Subject's Average Reticulocytes Percentage Over Time.
timeFrame: 6 months and annually for 8 years post-implant
measure: Subject's Average Score on the EQ-5D- Quality of Life Questionnaire at Baseline and 6 Months Post-Implant.
timeFrame: Baseline and 6 Months Post-Implant
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Portland
country: United States
facility: Providence Heart & Vascular Institute
state: Oregon
city: Salt Lake City
country: United States
facility: St. Marks Hospital
state: Utah
city: Innsbruck
country: Austria
facility: Universitatslinik fur Chirurgie
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Vancouver
country: Canada
facility: St. Paul's Hospital
city: Munich
country: Germany
facility: Liknik fur Herz und BefaBchirurgie Im Deuschen Herzzentrum
state: Lazarettstr
city: Hannover
country: Germany
facility: Klinik fur Herz-, Thorax-, Transplantations- und Gefabchirurgie
city: San Martin de Porres 4
country: Spain
facility: Hospital Peutra de Hierro
state: Madrid
city: Papworth Everard
country: United Kingdom
facility: Papworth Hospital NHS foundation Trust
state: Cambridge
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
state: Lancashire
Study officials:
References:
citation: 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.