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Trial record 1 of 1 for:    eartH TAVI
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Evaluation of Cerebral Thrombembolism After TAVR (EARTH - TAVR)

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ClinicalTrials.gov Identifier: NCT02758964
Recruitment Status : Completed
First Posted : May 3, 2016
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Ulf Landmesser, Charite University, Berlin, Germany

Brief Summary:
EARTH-TAVR is a diagnostic multicenter study to evaluate the occurrence and extent of cerebral embolization (total new lesion volume) in patients before TAVR versus 3 months after TAVR.

Condition or disease Intervention/treatment
Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Intracranial Embolism Other: MRI, neurocognitive Testing

Detailed Description:

Calcific aortic valve stenosis is the most common cause of aortic stenosis (AS) among adults in Europe and in the United States. The prevalence of moderate or severe AS was found to be age-dependent rising from 0.02% in patients aged 18-44 years to 2.8% in patients aged ≥ 75 years. Among patients at prohibitive surgical risk, TAVR has become the treatment of choice.The safety and efficacy of TAVR compared with medical management and SAVR has been demonstrated in clinical trials.The composite of the rate of all-cause death or stroke was 27% and 37% in TAVR patients after 1 and 2 years, respectively.Even though parts of the strokes occur during the peri-procedural period, the patients remain at risk of stroke throughout the first months after the procedure.

EARTH-TAVR is a diagnostic multicenter study performing in association with the GALILEO trial (NCT02556203), which is investigating cerebral embolization with MRI and neurocognitive testing in patients undergoing TAVR, who are treated with anticoagulation (Rivaroxaban/ASS) or DAPT (Clopidogrel/ASS). GALILEO is a global multicenter, open-label, randomized, event-driven, active-controlled study comparing a rivaroxaban-based antithrombotic strategy to an antiplatelet-based strategy after transcatheter aortic valve replacement (TAVR) to optimize clinical outcomes.

Investigators aim to investigate peri-interventional and delayed cerebral embolization in the early period (3 months) after TAVR and to analyze associations between neurocognitive parameters and cerebral embolization patterns in patients on different antithrombotic treatment regimes.

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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Cerebral Thrombembolism After TAVR
Study Start Date : September 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: MRI, neurocognitive Testing
    A cerebral MRI and neurocognitive testing will be performed before TAVR, before hospital discharge and after 3 months


Primary Outcome Measures :
  1. Total volume of new cerebral lesions on MRI, 3 months after TAVR versus Baseline [ Time Frame: 3 months after TAVR versus baseline ]

    Occurrence and extent of cerebral embolization in patients after TAVR measured by total volume of new ischemic cerebral lesions on DWI and FLAIR MRI.

    Total new lesion volume is defined as the sum volume of all new cerebral ischemic lesions on the 3 months post-procedural MRI relative to the pre-TAVR cerebral MRI scan (on diffusion weighted and FLAIR MRI images)



Secondary Outcome Measures :
  1. New lesion volume of cerebral embolization in patients treated with ASS and rivaroxaban 10mg OD versus an antiplatelet -based strategy with ASS and clopidogrel. [ Time Frame: 3 months post TAVR versus baseline ]
    Total new lesion volume is defined as the sum volume of all new cerebral ischemic lesions on the 3 months post-procedural MRI relative to the pre-TAVR cerebral MRI scan (on diffusion weighted and FLAIR MRI images).

  2. extent and location of new cerebral lesions early AFTER TAVR and after 3 months [ Time Frame: MRI after TAVR (0-7 days after TAVR) compared to 3 months after TAVR ]
    To evaluate cerebral embolisation, which is not procedure related, cerebral embolisation on MRI will be compared 3 months post TAVR versus the post-TAVR MRI scan

  3. Assessment of different neurocognitive tests (NIHSS-score, MOCA-score, MOT-score, PAL-score, RTI-score, SWM-score, AST-score, CAM-Score); change of sum scores before, after and 3 months after TAVR procedure. [ Time Frame: Before TAVR, post TAVR and after 3 months ]
    To evaluate neurologic function with a battery of neurocognitive tests and to correlate these findings to cerebral MRI scans

  4. Extent and localization of clinically apparent non-cerebral emboli after TAVR [ Time Frame: baseline, post TAVR and after 3 months ]
    To describe extent and localization of non-cerebral embolisation (e.g. pulmonary embolism, limb ischaemia...)

  5. Evaluation of possible changes in quality of life after TAVI with EQ-5D questionnaire sum score. [ Time Frame: Baseline versus 3 months following TAVR ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients 18 years or older wirth aortic valve stenosis receiving TAVR-Intervention.
Criteria

Inclusion Criteria:

  • Man or woman of 18 years of age or older
  • Via iliofemoral or subclavian access
  • Provide written IC

Exclusion Criteria:

  • Atrial fibrillation (AF), current or previous, with an ongoing indication for oral anticoagulant Treatment
  • Any other indication for continued treatment with any oral anticoagulant (OAC)
  • Known bleeding diathesis (such as but not limited to active internal bleeding, clinically significant bleeding, platelet count ≤ 50,000/mm3 at screening, hemoglobin level < 8.5 g/dL, active peptic ulcer or known gastrointestinal (GI) bleeding, history of intracranial hemorrhage or subdural hematoma)
  • Any indication for dual-antiplatelet therapy (DAPT) for more than 3 months after randomization (such as coronary, carotid or peripheral stent implantation)
  • Clinically overt stroke within the last 3 months
  • Planned coronary or vascular intervention or major surgery
  • Severe renal impairment (eGFR < 30 mL/min/1.73 m2) or on dialysis, or post-TAVR unresolved acute kidney injury with renal dysfunction stage 2 or higher
  • Moderate and severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy
  • Any contraindication for cerebral MRI, in particular:
  • non-MRI-conditional pacemakers
  • MRI conditional pacemakers <4 weeks after implant
  • any metal fragments in the eye
  • aneurysm clip in the brain
  • severe claustrophobia

Information from the National Library of Medicine

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): NCT02758964


Locations
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Germany
Charité - Universitätsmedizin Berlin, Campus Mitte
Berlin, Germany, 10117
Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany, 12203
Sponsors and Collaborators
Charite University, Berlin, Germany
Bayer
Investigators
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Principal Investigator: Ulf Landmesser, Prof. Dr. Charité - Universitätsmedizin Berlin, Department of Cardiology
Study Chair: Matthias Endres, Prof. Dr. Charité - Universitätsmedizin Berlin, Department of Neurology
Study Chair: Georg M Fröhlich, PD Charité - Universitätsmedizin Berlin, Department of Cardiology
Study Chair: Volkmar Falk, Professor German Heart Institute

Additional Information:
Publications:
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Responsible Party: Ulf Landmesser, Prof. Dr. Ulf Landmesser, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02758964    
Other Study ID Numbers: EARTH - TAVR 01
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Keywords provided by Ulf Landmesser, Charite University, Berlin, Germany:
TAVR
TAVI
Transcatheter Aortic Valve Replacement
Intracranial Embolism
Additional relevant MeSH terms:
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Intracranial Embolism
Embolism
Aortic Valve Stenosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heart Valve Diseases
Heart Diseases
Ventricular Outflow Obstruction
Intracranial Embolism and Thrombosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Thromboembolism