Portico TAVI Implant With Transfemoral Delivery System
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|ClinicalTrials.gov Identifier: NCT01493284|
Recruitment Status : Completed
First Posted : December 15, 2011
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Symptomatic Aortic Stenosis||Device: Transcatheter Aortic Valve Implantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||222 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment Of The St. Jude Medical Portico™ Transcatheter Aortic Valve Implant (TAVI) And The SJM TAVI Transfemoral Delivery System (Portico TF EU)|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||September 2016|
Experimental: Transfemoral Access
Transfemoral Access for transcatheter aortic valve implant
Device: Transcatheter Aortic Valve Implantation
Placement of the SJM Portico aortic valve with a transfemoral delivery system
- All Cause Mortality [ Time Frame: 30 days ]Number of participants that reported all cause mortality
- Number of Select Cardiovascular Adverse Events [ Time Frame: 30 days ]Number of participants with select cardiovascular adverse events
- Participant NYHA Classification at Day 30 [ Time Frame: day 30 ]
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.
Class I. Patients with cardiac disease but without resulting limitation of physical activity.
Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.
Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.
Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.
The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.
- Number of Participants With Acute Device Success [ Time Frame: 7 days ]
- Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system
- Correct position of the device in the proper anatomical location
- Intended performance of the prosthetic heart valve (Aortic Valve Area >1.2 cm2 and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, without moderate or severe prosthetic valve AR)
- Only one valve implanted in the proper anatomical location
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493284
|Adelaide Royal Hospital|
|Bad Nauheim, Germany|
|Heart Center Bernau|
|Asklepios Klinik-St. Georg|
|Klinikum der Universität Jena|
|Klinik fur Herzhirurgie Karlruhe GmbH|
|Medical Center Leeuwarden|
|Royal Victoria Hospital|
|Belfast, Northern Ireland, United Kingdom, BT12 6BA|
|Leicester, United Kingdom|
|London, United Kingdom|
|St. Thomas' Hospital|
|London, United Kingdom|
|Derriford Hospital, Plymouth|
|Plymouth, United Kingdom|
|Principal Investigator:||Ganesh Manoharan, MD||Royal Victoria Hospital|