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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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