Clinical trial NCT01651052: Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
Official title: Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Disorder
Aortic Valve Insufficiency
Aortic Valve Stenosis
Heart Failure
Coronary Artery Disease
Keywords: Aortic valve replacement/regurgitation
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2012-07-26
Enrollment: 133
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 this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.

Detailed description: This is a prospective, non-randomized, non-controlled observational clinical trial. Up to 200 subjects will be enrolled at up to 6 participating clinical sites. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic valve. Patients will be followed and assessed after implant for up to 5 years.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Require replacement of aortic valve
* Signed informed consent
* Willing to return to study site for follow-up visits

Exclusion Criteria:

* Active endocarditis/myocarditis (\< 3 months)
* Myocardial infarction (\< 30 days)
* Renal insufficiency/ End-stage renal disease
* Life expectancy (\< 1 year)
* Requires multiple valve replacement/repair
* Requiring emergent aortic valve surgery
* Pregnant or lactating

Primary outcomes:
measure: Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
timeFrame: Events occurring within 30 days of procedure
measure: Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
timeFrame: Events occurring >= 31 days and up through 5 years post-implant
Secondary outcomes:
measure: Subject's Average Mean Gradient Measurements
timeFrame: Baseline through 5-Year (at each scheduled follow-up visit)
measure: Subject's Average Effective Orifice Area Measurements
timeFrame: Baseline through 5-Year (at each scheduled follow-up visit)
measure: Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
timeFrame: 3-6 Months and 1 through 5 Years compared to baseline
measure: Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey
timeFrame: Baseline and one year follow-up
measure: Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
timeFrame: Baseline and 1 Year
Other outcomes:
measure: Subject's Average White Blood Cell Count
timeFrame: Baseline, 3-6 Months, and 1 through 5 Years
measure: Subject's Average Red Blood Cells Count
timeFrame: Baseline, 3-6 Months, and 1 through 5 Years
measure: Subject's Average Hemoglobin Count
timeFrame: Baseline, 3-6 months, and 1 through 5 years
measure: Subject's Average Hematocrit Percentage
timeFrame: Baseline, 3-6 Months, and 1 through 5 Years
measure: Subject's Average Platelet Count
timeFrame: Baseline, 3-6 Months, and 1 through 5 Years
measure: Subject's Average Plasma Free Hemoglobin
timeFrame: Baseline, 3-6 Months, and 1 through 5 Years
measure: Subject's Average Serum Creatinine
timeFrame: Baseline
measure: Subject's Average International Normalized Ratio
timeFrame: Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
measure: Subject's Average Partial Thromboplastin Time
timeFrame: Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
measure: Subject's Average Prothrombin Time
timeFrame: Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
Locations:
city: Kraków
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II
city: Warsaw
country: Poland
facility: Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego
Study officials:
affiliation: John Paul II Hospital
name: Jerzy Sadowski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cardinal Stefan Wyszyński Institute of Cardiology
name: Jacek Rozanski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De La Fuente AB, Wright GA, Olin JM, Duhay FG, Kapelak B, Bochenek M, Bartus K, Sadowski J. Advanced Integrity Preservation Technology Reduces Bioprosthesis Calcification While Preserving Performance and Safety. J Heart Valve Dis. 2015 Jan;24(1):101-9.
citation: Bartus K, Litwinowicz R, Kusmierczyk M, Bilewska A, Bochenek M, Stapor M, Wozniak S, Rozanski J, Sadowski J, Kapelak B. Primary safety and effectiveness feasibility study after surgical aortic valve replacement with a new generation bioprosthesis: one-year outcomes. Kardiol Pol. 2018;76(3):618-624. doi: 10.5603/KP.a2017.0262. Epub 2018 Jan 3.
citation: Sadowski J, Bartus K, Kapelak B, Chung A, Stapor M, Bochenek M. Aortic valve replacement with a novel anti-calcification technology platform. Kardiol Pol. 2015;73(5):317-22. doi: 10.5603/KP.a2014.0214. Epub 2014 Nov 5.
citation: Bartus K, Litwinowicz R, Bilewska A, Stapor M, Bochenek M, Rozanski J, Sadowski J, Filip G, Kusmierczyk M, Kapelak B. Final 5-year outcomes following aortic valve replacement with a RESILIA tissue bioprosthesis. Eur J Cardiothorac Surg. 2021 Jan 29;59(2):434-441. doi: 10.1093/ejcts/ezaa311.