Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the St. Jude Medical Transfemoral Delivery System
This study has been completed.
Information provided by (Responsible Party):
St. Jude Medical
First received: December 2, 2011
Last updated: September 18, 2014
Last verified: September 2014
Collect and evaluate the long term safety data.
||Observational Model: Cohort
||Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the SJM Transfemoral Delivery System
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2012 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients that are candidate for implantation or have been implanted with the St. Jude Medical 23mm Portico Transcatheter heart valve.
- Subject has given written study Informed Consent for participation prior to any study procedures.
- Subject is ≥ 18 years of age or legal age in host country at time of consent.
- Subject currently has a 23mm SJM Portico Transfemoral Transcatheter Heart Valve
- Subject currently participating in another investigational device or drug study.
- Subject is unable or unwilling to return for the required follow-up visits.
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
|l'Institut universitaire de cardiologie et de pneumologie de Québec
|Quebec, Canada |
|St. Paul's Hospital
|Vancouver, Canada |
St. Jude Medical
||John Webb, MD
||Providence Health Care - St. Paul's Hospital
No publications provided
||St. Jude Medical
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 2, 2011
||September 18, 2014
||Canada: Health Canada
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 30, 2015
Aortic Valve Stenosis
Heart Valve Diseases
Ventricular Outflow Obstruction