NCT02758964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

2.3 years

First QC Date

April 24, 2016

Last Update Submit

March 31, 2019

Conditions

Aortic Valve StenosisTranscatheter Aortic Valve ReplacementIntracranial Embolism

Keywords

TAVRTAVITranscatheter Aortic Valve ReplacementIntracranial Embolism

Outcome Measures

Primary Outcomes (1)

  • Total volume of new cerebral lesions on MRI, 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)

    3 months after TAVR versus baseline

Secondary Outcomes (5)

  • New lesion volume of cerebral embolization in patients treated with ASS and rivaroxaban 10mg OD versus an antiplatelet -based strategy with ASS and clopidogrel.

    3 months post TAVR versus baseline

  • extent and location of new cerebral lesions early AFTER TAVR and after 3 months

    MRI after TAVR (0-7 days after TAVR) compared to 3 months after TAVR

  • 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.

    Before TAVR, post TAVR and after 3 months

  • Extent and localization of clinically apparent non-cerebral emboli after TAVR

    baseline, post TAVR and after 3 months

  • Evaluation of possible changes in quality of life after TAVI with EQ-5D questionnaire sum score.

    Baseline versus 3 months following TAVR

Interventions

MRI, neurocognitive TestingOTHER

A cerebral MRI and neurocognitive testing will be performed before TAVR, before hospital discharge and after 3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients 18 years or older wirth aortic valve stenosis receiving TAVR-Intervention.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charité - Universitätsmedizin Berlin, Campus Mitte

Berlin, 10117, Germany

Location

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Related Publications (2)

  • Holmes DR Jr, Brennan JM, Rumsfeld JS, Dai D, O'Brien SM, Vemulapalli S, Edwards FH, Carroll J, Shahian D, Grover F, Tuzcu EM, Peterson ED, Brindis RG, Mack MJ; STS/ACC TVT Registry. Clinical outcomes at 1 year following transcatheter aortic valve replacement. JAMA. 2015 Mar 10;313(10):1019-28. doi: 10.1001/jama.2015.1474.

    PMID: 25756438BACKGROUND

  • Osnabrugge RL, Mylotte D, Head SJ, Van Mieghem NM, Nkomo VT, LeReun CM, Bogers AJ, Piazza N, Kappetein AP. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013 Sep 10;62(11):1002-12. doi: 10.1016/j.jacc.2013.05.015. Epub 2013 May 30.

    PMID: 23727214BACKGROUND

Related Links

MeSH Terms

Conditions

Aortic Valve StenosisIntracranial Embolism

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionIntracranial Embolism and ThrombosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesThromboembolismEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Ulf Landmesser, Prof. Dr.

    Charité - Universitätsmedizin Berlin, Department of Cardiology

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Ulf Landmesser

Study Record Dates

First Submitted

April 24, 2016

First Posted

May 3, 2016

Study Start

September 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

April 2, 2019

Record last verified: 2019-03

Locations

DE(2)