Long Term Follow Up Study of the St. Jude Medical Trifecta Valve

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01593917
First received: May 4, 2012
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

To collect long term follow up study data of the Trifecta valve in subjects who had the Trifecta valve implanted during the IDE study.


Condition
Aortic Valve Insufficiency
Aortic Valve Regurgitation
Aortic Valve Stenosis
Aortic Valve Incompetence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Collecting long term valve related events [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    The primary objective is to collect long-term study data including long term valve-related events of the Trifecta valve


Estimated Enrollment: 650
Study Start Date: June 2012
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subjects previously implanted with a Trifecta valve
Subjects enrolled in this clinical study received the Trifecta valve during the investigational study that was conducted to obtain FDA approval

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects previously implanted with a Trifecta prosthetic valve

Criteria

Inclusion Criteria:

  • Patient currently has a Trifecta valve that was implanted
  • Patient met eligibility criteria prior to enrollment in the Trifecta IDE study
  • Patient agrees to complete all required follow-up visits
  • Patient provided written informed consent prior to any study related procedure as approved by the governing Institutional Review Board or the Ethics Committee of the investigational site

Exclusion Criteria:

  • Patient is currently participating or planning to participate in any other study unless approved by SJM
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593917

Contacts
Contact: Kelly Erickson 651-756-6580 kaerickson@sjm.com

Locations
United States, California
Keck School of Medicine of University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Becky M Lopez, RN    323-442-6226    becky.lopez@med.usc.edu   
Contact: Shadi Van Trease, CRC    323-442-6252    Shadi.Vantrease@med.usc.edu   
Principal Investigator: Vaughn Starnes, MD         
Sub-Investigator: Mark Cunningham, MD         
Sub-Investigator: Craig Baker, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Roberta C. Palumbo, ADN    216-444-8744    palumbr@ccf.org   
Contact: Kathleen Sankovic, RN, CCRP    216-445-4989    sankovk@ccf.org   
Principal Investigator: A. Marc Gillinov, MD         
Sub-Investigator: Eric Roselli, MD         
Sub-Investigator: Gosta Pettersson, MD         
United States, Pennsylvania
Lankenau Medical Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Ann M Chikowski, BSN    484-476-8579    chikowskia@mlhs.org   
Contact: Susan K Herring, BSN M.Ed    484-476-8514    herrings@mlhs.org   
Principal Investigator: Scott M Goldman, MD         
Sub-Investigator: Francis D Ferdinand, MD         
Sub-Investigator: Roberto Rodriquez, MD         
Canada, British Columbia
University of British Columbia Department of Surgery, Division of Cardiovascular Surgery; St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6J 2G7
Contact: Catherine Mok       CMok@providencehealth.bc.ca   
Contact: Miroslav Svetik       Miroslav.Svetik@vch.ca)   
Principal Investigator: Anson Cheung, BSc, MD, MSc         
Sub-Investigator: Jamil Bashir, BMSc, MD         
Sub-Investigator: Paul Bui, BSc, MD         
Sub-Investigator: Richard Cook, BSc, MD, MSc         
Sub-Investigator: Samuel Lichtenstein, BSc, PhD, MD         
Sub-Investigator: Hilton Ling, BMd, MCh, MD         
Sub-Investigator: Peter Skarsgard, MD, PhD         
Sub-Investigator: Jian Ye, MD, MSc         
Sub-Investigator: James Abel, MD         
Canada
Institut Universitaire de Cardiologie et Pneumologie de Quebec Recruiting
Quebec, Canada, G1V 4G5
Contact: Suzanne Keilani       Suzanne.Keilani@criucpq.ulaval.ca   
Contact: Marie-Josee Goulet, RN    418-656-8711 ext 2768    marie-josee.goulet@criucpq.ulaval.ca   
Principal Investigator: Eric Charbonneau, MD         
Sub-Investigator: Francois Dagenais, MD         
Sub-Investigator: Pierre Voisine, MD         
Sub-Investigator: Eric Dumont, MD         
Sub-Investigator: Richard Baillot, MD         
Sub-Investigator: Siamak Mohammadi, MD         
Sub-Investigator: Mario Senechal, MD         
Sub-Investigator: Jacques Metras, MD         
Sub-Investigator: Daniel Doyle, MD         
Sub-Investigator: Patrick Mathieu, MD         
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Director: Urban Lonn, MD St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01593917     History of Changes
Other Study ID Numbers: 1104
Study First Received: May 4, 2012
Last Updated: October 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Medical:
Aortic valve
Heart valve
Tissue valve
Bioprosthesis

Additional relevant MeSH terms:
Aortic Valve Insufficiency
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on July 23, 2014