CompletedNot Applicable

Implantable Sensor in Aortic Stenosis

United Kingdom17 participantsStarted 2017-08-15

Plain-language summary

To establish the relationship between a panel of biological markers obtained from the REVEAL Linq device and exercise performance as judged by cardiopulmonary exercise testing

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Severe aortic stenosis defined as effective orifice area (EOA) \< 1.0 cm2 (or 0.6 cm2/m2 when indexed for body surface area) and peak velocity \> 4.0 m/s or mean gradient \> 40mmHg
✓. No AS attributable symptoms during clinical consultation
✓. Informed consent
✓. Aged 18 years of age or over

Exclusion criteria

✕. Left ventricular ejection fraction \<50%
✕. Severe mitral regurgitation
✕. PA systolic pressure \>40mmHg
✕. Ischaemic heart disease with evidence of ongoing ischaemia
✕. Anginal chest pain
✕. Inability to cycle
✕. Unrecordable echo windows
✕. Alternative pathology like to be life limiting within 2 years

What they're measuring

To establish the relationship between a panel of biological markers obtained from the REVEAL Linq device and exercise performance as judged by cardiopulmonary exercise testing.

Timeframe: 12 months

The regressive relationship between total weekly activity from the Reveal Linq and change in VO2 peak /Oxygen Uptake Efficiency Slope (OUES) established by cardiopulmonary exercise testing between visits.

Timeframe: 12 months

Trial details

NCT IDNCT06826183

SponsorBarts & The London NHS Trust

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-03-09

View on ClinicalTrials.gov More Aortic Stenosis trials