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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
Sponsor:
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
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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
  Description
Transfemoral Transfemoral access

Participant Flow:   Overall Study
    Transfemoral
STARTED   222 
COMPLETED   161 
NOT COMPLETED   61 
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
  Description
Transfemoral Transfemoral access

Baseline Measures
   Transfemoral 
Overall Participants Analyzed 
[Units: Participants]
 222 
Age 
[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
 175 
[1]

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
 68 
Porcelain aorta 
[Units: Participants]
Count of Participants
 8 
History of atrial fibrillation 
[Units: Participants]
Count of Participants
 85 
Renal failure/insufficiency 
[Units: Participants]
Count of Participants
 73 


  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
e-mail: alicia.kimber@abbott.com


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

Responsible Party: St. Jude Medical
ClinicalTrials.gov 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