Implantable Sensor in Aortic Stenosis
ISAS
The Use of Activity and Impedance From a Continuous, Implantable Sensor to Detect Deterioration in Asymptomatic Patients With Severe Aortic Stenosis (AS) Under a Watchful Waiting Program
1 other identifier
observational
17
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2017
CompletedFirst Submitted
Initial submission to the registry
January 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2020
CompletedFirst Posted
Study publicly available on registry
February 13, 2025
CompletedFebruary 13, 2025
February 1, 2025
1.6 years
January 23, 2019
February 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
12 months
Secondary Outcomes (5)
The relationship between weekly heart rate variability and VO2 peak /OUES
12 months
The relationship between weekly heart rate and VO2 peak /OUES
12 months
The relationship between acoustic murmur intensity and VO2 peak /OUES
12 months
The relationship between S1/S2 intensity and VO2 peak/ OUES
12 months
The relationship between murmur intensity augmentation and VO2 peak/OUES
12 months
Interventions
Implantable loop recorder
Eligibility Criteria
Asymptomatic severe aortic stenosis
You may qualify if:
- 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
You may not qualify if:
- 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
- Chronic renal failure (EGFR\<30)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Barts & The London NHS Trustlead
- East Sussex Hospitals NHS Trustcollaborator
Study Sites (1)
Barts Health NHS Trust
London, EC1A 7BE, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guy Lloyd
Barts & The London NHS Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2019
First Posted
February 13, 2025
Study Start
August 15, 2017
Primary Completion
March 9, 2019
Study Completion
March 9, 2020
Last Updated
February 13, 2025
Record last verified: 2025-02