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Cerebral Protection in Transcatheter Aortic Valve Replacement

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ClinicalTrials.gov Identifier: NCT02214277
Recruitment Status : Completed
First Posted : August 12, 2014
Results First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Claret Medical

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Severe Symptomatic Calcified Native Aortic Valve Stenosis
Interventions: Device: Cerebral Protection System-The SENTINEL System with TAVR
Device: TAVR

  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
  Description
Safety Arm

Safety Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study received safety follow-up at discharge, at 30 days and 90 days post-procedure; and neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure. Safety Arm patients did not receive MRI.

The Safety Arm was combined with the Test Arm for analysis of safety endpoints.

Test Arm

Test Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days post-procedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days post-procedure; Quality of Life assessment at baseline, 30 days and 90 days; and histopathological evaluation of debris captured in the Sentinel device filters.

The Test Arm was compared to the Control Arm for analysis of MRI related endpoints, and was combined with the Safety Arm for analysis of safety endpoints.

Control Arm

Control Arm patients received TAVR only. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days post-procedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days post-procedure; and Quality of Life assessment at baseline, 30 days and 90 days.

The Control Arm was compared to the Test arm for MRI related endpoints.


Participant Flow:   Overall Study
    Safety Arm   Test Arm   Control Arm
STARTED   123   121   119 
COMPLETED   104   96   85 
NOT COMPLETED   19   25   34 



  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.
No text entered.

Reporting Groups
  Description
Safety Arm Safety Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study received safety follow-up at discharge, at 30 days and 90 days post-procedure; and neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure.
Test Arm Test Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days post-procedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days post-procedure; Quality of Life assessment at baseline, 30 days and 90 days; and histopathological evaluation of debris captured in the Sentinel device filters.
Control Arm Control Arm patients received TAVR only. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days post-procedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days post-procedure; and Quality of Life assessment at baseline, 30 days and 90 days.
Total Total of all reporting groups

Baseline Measures
   Safety Arm   Test Arm   Control Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 123   121   119   363 
Age 
[Units: Years]
Mean (Standard Deviation)
 81.5  (8.98)   82.0  (7.95)   83.4  (7.90)   82.3  (8.31) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      68  55.3%      63  52.1%      58  48.7%      189  52.1% 
Male      55  44.7%      58  47.9%      61  51.3%      174  47.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      0   0.0%      3   2.5%      1   0.8%      4   1.1% 
Not Hispanic or Latino      123 100.0%      118  97.5%      118  99.2%      359  98.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      1   0.8%      1   0.3% 
Asian      2   1.6%      1   0.8%      0   0.0%      3   0.8% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      8   6.5%      1   0.8%      1   0.8%      10   2.8% 
White      109  88.6%      115  95.0%      115  96.6%      339  93.4% 
More than one race      1   0.8%      2   1.7%      2   1.7%      5   1.4% 
Unknown or Not Reported      3   2.4%      2   1.7%      0   0.0%      5   1.4% 
Region of Enrollment 
[Units: Participants]
       
United States   98   95   96   289 
Germany   25   26   23   74 
STS PROM Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 6.2  (3.17)   6.4  (3.28)   7.5  (4.66)   6.7  (3.79) 
[1] The Society of Thoracic Surgeons’ (STS) predicted risk of mortality (PROM) score is used to predict the risk of operative mortality and morbidity of surgery. It is based on patient demographic and clinical variables, and scores are divided into four categories: low risk (<4%),intermediate risk (>=4% to <8%), high risk (>=8% to <12%) ,very high risk (>=12%).
History of Atrial Fibrillation 
[Units: Participants]
Count of Participants
 37   42   36   115 


  Outcome Measures

1.  Primary:   Reduction in Median Total New Lesion Volume in Protected Territories Between Test and Control Arms as Assessed by DW-MRI at Day 2-7 Post-procedure.   [ Time Frame: Day 2-7 Post-Procedure ]

2.  Primary:   Patients With Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days   [ Time Frame: 30 Days Post-Procedure ]

3.  Secondary:   Captured Debris Histopathology (Observational)   [ Time Frame: Post-procedure ]


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Director of Clinical Research
Organization: Claret Medical
phone: 707-528-9300
e-mail: info@claretmedical.com


Publications of Results:

Responsible Party: Claret Medical
ClinicalTrials.gov Identifier: NCT02214277     History of Changes
Other Study ID Numbers: CP-10836
First Submitted: August 8, 2014
First Posted: August 12, 2014
Results First Submitted: September 1, 2017
Results First Posted: May 11, 2018
Last Update Posted: May 11, 2018