Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the St. Jude Medical Transfemoral Delivery System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01497418
First received: December 2, 2011
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

Collect and evaluate the long term safety data.


Condition
Aortic Valve Stenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the SJM Transfemoral Delivery System

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • The objective of this study is to retrospectively and prospectively collect and evaluate the long term safety of the 23mm Portico Transcatheter Aortic Heart [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Data will be collected at 3 months, 6 months, and 12 months post-implant.


Enrollment: 2
Study Start Date: December 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Detailed Description:

The purpose of this study is to collect and evaluate the long term safety data of the 23mm Portico™ Transcatheter Heart Valve and the transfemoral Delivery System previously implanted in subjects with aortic valve disease.

  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

Patients that are candidate for implantation or have been implanted with the St. Jude Medical 23mm Portico Transcatheter heart valve.

Criteria

Inclusion Criteria:

  1. Subject has given written study Informed Consent for participation prior to any study procedures.
  2. Subject is ≥ 18 years of age or legal age in host country at time of consent.
  3. Subject currently has a 23mm SJM Portico Transfemoral Transcatheter Heart Valve

Exclusion Criteria:

  1. Subject currently participating in another investigational device or drug study.
  2. Subject is unable or unwilling to return for the required follow-up visits.
  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: NCT01497418

Locations
Canada
l'Institut universitaire de cardiologie et de pneumologie de Québec
Quebec, Canada
St. Paul's Hospital
Vancouver, Canada
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: John Webb, MD Providence Health Care - St. Paul's Hospital
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01497418     History of Changes
Other Study ID Numbers: 1102
Study First Received: December 2, 2011
Last Updated: March 12, 2014
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on August 28, 2014