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Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

This study is currently recruiting participants.
Verified November 2012 by Edwards Lifesciences
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01651052
First received: July 18, 2012
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Aortic Valve Disorder
Aortic Valve Insufficiency
Aortic Valve Stenosis
Heart Failure
Coronary Artery Disease
 Procedure: Heart Valve Surgery

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • Safety Endpoints [ Time Frame: Intraoperative, discharge, 3 months, and annual scheduled follow-up visits (5 Years) ] [ Designated as safety issue: Yes ]

    Descriptive information of early rates and late linearized rates of the follow-ing:

    • Structural valve deterioration
    • Thromboembolism
    • All bleeding/hemorrhage
    • Major bleeding/hemorrhage
    • All paravalvular leak
    • Major paravalvular leak
    • Non-structural valve dysfunction
    • Endocarditis
    • Hemolysis
    • All cause mortality
    • Trial valve-related mortality
    • Explant


Secondary Outcome Measures:
  • Performance Endpoints [ Time Frame: 5-Years (at each scheduled follow-up visit) ] [ Designated as safety issue: No ]
    • Clinically acceptable hemodynamic performance confirmed by core lab evaluation of echocardiography
    • New York Heart Association (NYHA) functional class com-pared to baseline
    • Change in Quality of Life questionnaires EQ-5D (EuroQol) and Short Form 12 version 2 (SF-12v2) from baseline/screening to 1-year


Estimated Enrollment: 200
Study Start Date: July 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aortic Bioprosthesis, Model 11000
Aortic valve replacement therapy
 Procedure: Heart Valve Surgery
Implant of an aortic valve, Model 11000

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651052

Locations
Poland
Krakowski Szpital Specjalistyczny im. Jana Pawła II Recruiting
Kraków, Poland, 31-202
Contact: Krzysztof Bartus, MD     +48 5022 94 250     cool_chris@interia.pl    
Contact: Maciek Bochenek, MD     +48 6065 15 870     mbochenek@poczta.fm    
Principal Investigator: Jerzy Sadowski, MD            
Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego Recruiting
Warsaw, Poland, 04-628
Contact: Agata Bilewska, MD,Phd     +48 (22) 8154901     agatabilewska@o2.pl    
Contact: Mariusz Kuśmierczyk, MD, PhD     +48 (22) 3434610     mkusmierczyk1971@gmail.com    
Principal Investigator: Jacek Rozanski, MD, PhD            
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Study Director: Carol Renner Edwards Lifesciences
  More Information

No publications provided

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01651052     History of Changes
Other Study ID Numbers: 2010-03
Study First Received: July 18, 2012
Last Updated: November 27, 2012
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Edwards Lifesciences:
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 May 19, 2013