Portico TAVI Implant With Transfemoral Delivery System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01493284
Recruitment Status : Completed
First Posted : December 15, 2011
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Information provided by (Responsible Party):
St. Jude Medical

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Symptomatic Aortic Stenosis
Intervention: Device: Transcatheter Aortic Valve Implantation

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Transfemoral Transfemoral access

Participant Flow:   Overall Study
STARTED   222 
Death                29 
Withdrawal by Subject                32 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Transfemoral Transfemoral access

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 83.0  (4.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      165  74.3% 
Male      57  25.7% 
Region of Enrollment 
[Units: Participants]
Count of Participants
Netherlands   15 
Denmark   3 
United Kingdom   48 
Australia   15 
Germany   141 
STS risk score of mortality [1] 
[Units: Percentage]
Mean (Standard Deviation)
 5.8  (3.3) 
[1] The Society of Thoracic Surgeons (STS) score measures patient risk of operative mortality and morbidity after adult cardiac surgery on a scale that ranges from 0% to 100%, with higher numbers indicating greater risk.
NYHA class III/IV [1] 
[Units: Participants]
Count of Participants

NYHA Class I: Subjects with cardiac disease but without resulting limitations of physical activity.

NYHA Class II: Subjects with cardiac disease resulting in slight limitation of physical activity.

NYHA Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.

NYHA Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.

History of pulmonary hypertension 
[Units: Participants]
Count of Participants
Porcelain aorta 
[Units: Participants]
Count of Participants
History of atrial fibrillation 
[Units: Participants]
Count of Participants
Renal failure/insufficiency 
[Units: Participants]
Count of Participants

  Outcome Measures

1.  Primary:   All Cause Mortality   [ Time Frame: 30 days ]

2.  Secondary:   Number of Select Cardiovascular Adverse Events   [ Time Frame: 30 days ]

3.  Secondary:   Participant NYHA Classification at Day 30   [ Time Frame: day 30 ]

4.  Secondary:   Number of Participants With Acute Device Success   [ Time Frame: 7 days ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Sr Clinical Scientist
Organization: St Jude Medical
phone: 4159179696

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: St. Jude Medical Identifier: NCT01493284     History of Changes
Other Study ID Numbers: 1105
First Submitted: December 5, 2011
First Posted: December 15, 2011
Results First Submitted: March 15, 2017
Results First Posted: April 23, 2018
Last Update Posted: April 23, 2018