Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

NCT01651052 | Completed Results DMC

• 1 other identifier: 2010-03
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Aortic valve replacement/regurgitation

Outcome Measures

Primary Outcomes (2)

• Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)

  Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100

  Events occurring within 30 days of procedure

• Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)

  Number of late events divided by the total number of late patient years x 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).

  Events occurring >= 31 days and up through 5 years post-implant

Secondary Outcomes (5)

• Subject's Average Mean Gradient Measurements

  Baseline through 5-Year (at each scheduled follow-up visit)

• Subject's Average Effective Orifice Area Measurements

  Baseline through 5-Year (at each scheduled follow-up visit)

• Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.

  3-6 Months and 1 through 5 Years compared to baseline

• Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey

  Baseline and one year follow-up

• Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time

  Baseline and 1 Year

Other Outcomes (10)

• Subject's Average White Blood Cell Count

  Baseline, 3-6 Months, and 1 through 5 Years

• Subject's Average Red Blood Cells Count

  Baseline, 3-6 Months, and 1 through 5 Years

• Subject's Average Hemoglobin Count

  Baseline, 3-6 months, and 1 through 5 years

Study Arms (1)

Aortic Bioprosthesis, Model 11000

EXPERIMENTAL

Aortic valve replacement therapy

Procedure: Heart Valve Surgery

Interventions

Heart Valve Surgery PROCEDURE

Implant of an aortic valve, Model 11000

Aortic Bioprosthesis, Model 11000

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (2)

Krakowski Szpital Specjalistyczny im. Jana Pawła II

Krakow, 31-202, Poland

Location

Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego

Warsaw, 04-628, Poland

Location

Related Publications (4)

• 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.

  PMID: 26182627 BACKGROUND

• 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.

  PMID: 29297188 RESULT

• 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.

  PMID: 25371311 RESULT

• 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.

  PMID: 33141188 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Mary Edwards, VP Clinical and Regulatory Affairs, Surgical Structural Heart
• Organization: Edwards Lifesciences, LLC

mary_edwards@edwards.com

949-250-2500

Study Officials

• Jerzy Sadowski, MD

  John Paul II Hospital

  PRINCIPAL INVESTIGATOR

• Jacek Rozanski, MD

  The Cardinal Stefan Wyszyński Institute of Cardiology

  PRINCIPAL INVESTIGATOR

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 18, 2012
• First Posted: July 26, 2012
• Study Start: July 1, 2011
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 26, 2019
• Results First Posted: July 26, 2019

Record last verified: 2019-07

Locations

PL (2)