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    Clinical Trial Results:
    EVALUATION OF CEREBRAL THROMBOEMBOLISM AFTER TAVR

    Summary
    EudraCT number
    		 2016-001777-33
    Trial protocol
    		 DE  
    Global end of trial date
    02 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jun 2022
    First version publication date
    04 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EARTH-TAVR01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02758964
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité Universitätsmedizin Berlin
    Sponsor organisation address
    HIndenburgdamm 30 , Berlin, Germany, 12203
    Public contact
    Clinical Trials Contact, Department of Cardiology, 0049 030450513702, ulf.landmesser@charite.de
    Scientific contact
    Clinical Trials Contact, Department of Cardiology, 0049 030450513702, ulf.landmesser@charite.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the occurrence and extent of cerebral embolization (total new lesion volume) in patients before TAVR versus 3 months after TAVR by cerebral MRI scans. The EARTH TAVR study investigates cerebral emboli by MRI, neurocognitive function and includes a neurological examination before TAVR, 1-2 days and 3 months after TAVR in conjunction with the GALILEO study (where patients are randomised to anticoagulation or DAPT after TAVI). In this way, a distinction can be made between procedural events directly associated with TAVR and events that could have been avoided in the course of the procedure (embolisms associated with undetected atrial fibrillation, thrombotic deposits on the valve prosthesis, etc.).
    Protection of trial subjects
    - accurate selection of trial subjects according to inclusion and exclusion criteria - follow-up visits to assess concomitant drug therapy and assess potential drug interactions and take early action - follow-up visits to assess (serious) adverse events
    Background therapy
    		 There is no specific treatment in connection to the EARTH TAVR trial. However, the GALILEO study assesses two antithrombotic strategies post-successful TAVR and treatments and dosing details of the GALILEO trial are described in its study protocol.
    Evidence for comparator
    		 here is no specific treatment in connection to the EARTH TAVR trial. However, the GALILEO study assesses two antithrombotic strategies post-successful TAVR and treatments and dosing details of the GALILEO trial are described in its study protocol.
    Actual start date of recruitment
    01 Jul 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 55
    Worldwide total number of subjects
    55
    EEA total number of subjects
    55
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    3
    From 65 to 84 years
    41
    85 years and over
    11

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruitment of 54 study participants was ongoing from 2016-2018 in Germany.

    Pre-assignment
    Screening details
    		 pre-TAVR assignment as part of clinical routine: TTE, angiogram, TAVR CT

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    this is an observational study as sub-study of the randomized-controlled, not blinded GALILEO trial. In the observational period of the EARTH TAVR study, there is no blinding implementation.

    Arms
    Arm title
    		 MRI, neurocognitive testing
    Arm description
    		 trial subjects received cerebral MRI and extensive neurocognitive testing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RIVAROXABAN
    Investigational medicinal product code
    366789-02-8
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    not applicable. SEE study GALILEO trial

    Number of subjects in period 1
    		MRI, neurocognitive testing
    Started
    55
    Completed
    55

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 55 55
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 79.4 ( 5.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 42 42
        Male
    		 13 13

    End points

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    End points reporting groups
    Reporting group title
    MRI, neurocognitive testing
    Reporting group description
    		 trial subjects received cerebral MRI and extensive neurocognitive testing.

    Subject analysis set title
    Δ 90 days vs post TAVR FUP
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    FUP, Follow-up

    Subject analysis set title
    Δ 90 days FUP vs baseline
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    FUP, Follow-up

    Primary: Δ post TAVR vs baseline

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    End point title
    		 Δ post TAVR vs baseline
    End point description
    Change of the Diffusion-weighted imaging (DWI) volume
    End point type
    Primary
    End point timeframe
    from baseline up to 48h post TAVR
    End point values
    		 MRI, neurocognitive testing Δ 90 days vs post TAVR FUP Δ 90 days FUP vs baseline
    Number of subjects analysed
    28
    25
    30
    Units: cm³
        arithmetic mean (confidence interval 95%)
    0.32 (0.12 to 0.67)
    -.37 (-0.68 to -0.13)
    0 (0 to 0)
    Statistical analysis title
    		 Change of the Diffusion-weighted imaging volume
    Comparison groups
    MRI, neurocognitive testing v Δ 90 days vs post TAVR FUP v Δ 90 days FUP vs baseline
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.025
    Method
    		 Logrank
    Confidence interval

    Secondary: AIR Imaging lesions

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    End point title
    		 AIR Imaging lesions
    End point description
    FLAIR, the fluidattenuated inversion recovery;
    End point type
    Secondary
    End point timeframe
    48h post-TAVR
    End point values
    		 MRI, neurocognitive testing
    Number of subjects analysed
    28
    Units: Count
        arithmetic mean (confidence interval 95%)
    3.5 (2 to 7)
    No statistical analyses for this end point

    Secondary: FLAIR Imaging volume

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    End point title
    		 FLAIR Imaging volume
    End point description
    End point type
    Secondary
    End point timeframe
    90 days after TAVR; Fallow up
    End point values
    		 MRI, neurocognitive testing
    Number of subjects analysed
    30
    Units: volume cm³
        arithmetic mean (confidence interval 95%)
    0.11 (0.07 to 0.34)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    baseline until 3 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 own
    Dictionary version
    1
    Reporting groups
    Reporting group title
    MRI, neurocognitive testing
    Reporting group description
    		 -

    Serious adverse events
    		 MRI, neurocognitive testing
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 55 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 MRI, neurocognitive testing
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 55 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No AEs and SAEs were reported.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/34474587
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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