Understanding risks in patients with aortic stenosis
Mechanisms of Excess Risk in Aortic STEnosis After Aortic Valve Replacement
University College, London · NCT04627987
This study is trying to see how heart scarring affects the risk of death in people with aortic stenosis before and after they have surgery to replace their heart valve.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 192 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University College, London (other) |
| Locations | 1 site (London) |
| Trial ID | NCT04627987 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the mechanisms behind the increased risk of mortality in patients with aortic stenosis who have heart scarring. It involves using cardiac MRI scans to detect scarring before aortic valve replacement and monitoring patients post-surgery with a small implanted device that tracks heart activity. The study will follow participants for an average of three years to gather data on heart failure and arrhythmias, ultimately seeking to improve patient outcomes through better understanding of these risks.
Who should consider this trial
Good fit: Ideal candidates are patients with symptomatic severe aortic stenosis who are referred for surgical or transcatheter aortic valve replacement.
Not a fit: Patients with significant other valve diseases, certain cardiomyopathies, or those unable to complete the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier interventions and tailored treatments for patients with aortic stenosis, potentially reducing mortality rates.
How similar studies have performed: While there have been studies on aortic stenosis and valve replacement, this specific approach focusing on scarring and continuous monitoring is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with symptomatic severe aortic stenosis referred for surgical or transcatheter AVR (one out of: effective orifice area \[EOA\] \<1.0 cm2 , indexed EOA of 0.6cm/m2, peak velocity \>4.0 m/s or mean gradient \>40mmHg). Exclusion Criteria: * More than moderate valve disease other than AS * Diagnosis of dilated or hypertrophic cardiomyopathy, pregnancy/breast feeding * eGFR \<30ml/min, CMR incompatible devices * Inability to complete the protocol * Other conditions that would prevent participation in the study. * Adenosine perfusion will not be performed in patients with AV block, severe asthma/COPD or LVEF\<40%.
Where this trial is running
London
- Barts Heart Centre — London, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Thomas A Treibel, MBBS PhD
- Email: thomas.treibel.12@ucl.ac.uk
- Phone: 020 3416 5000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aortic Stenosis, Non-Sustained VT, Heart Failure, Late gadolinium enhancement, Tissue characterisation, Arrhythmia, Sudden cardiac death, Heart failure