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Aortic Valve StenosisEARTH - TAVRNCT02758964

Evaluation of Cerebral Thrombembolism After TAVR

An observational study of Aortic Valve Stenosis and Transcatheter Aortic Valve Replacement, run by Charite University, Berlin, Germany at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MRI, neurocognitive Testing
How many people
55 participants
Where
2 sitesGermany
Study dates
Sep 2016to Jan 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Charité - Universitätsmedizin Berlin, Campus Mitte

    Berlin, 10117

  • Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin

    Berlin, 12203

Other trials in Germany

About this study

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.

Read the 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.

Being tested
MRI, neurocognitive Testing
Keywords
TAVR, TAVI, Transcatheter Aortic Valve Replacement, Intracranial Embolism
Medical subject headings
Aortic Valve Stenosis, Intracranial Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI, neurocognitive TestingOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 3 months after TAVR versus baseline

Secondary outcomes (5)

  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.

    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).

    Measured: 3 months post TAVR versus baseline

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

    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

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

  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.

    To evaluate neurologic function with a battery of neurocognitive tests and to correlate these findings to cerebral MRI scans

    Measured: Before TAVR, post TAVR and after 3 months

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

    To describe extent and localization of non-cerebral embolisation (e.g. pulmonary embolism, limb ischaemia...)

    Measured: baseline, post TAVR and after 3 months

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

    Measured: Baseline versus 3 months following TAVR

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionJan 2019
  4. Study completionJan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02758964
Sponsor's protocol ID
EARTH - TAVR 01
Acronym
EARTH - TAVR
Status last verified
Mar 2019
First submitted
24 Apr 2016
Last updated
2 Apr 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25756438

  • 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.

    PubMed 23727214

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Valve Stenosis and Transcatheter Aortic Valve Replacement, run by Charite University, Berlin, Germany at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total volume of new cerebral lesions on MRI, 3 months after TAVR versus Baseline (time frame: 3 months after TAVR versus baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02758964, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.

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