Mechanisms of excess risk in aortic stenosis after aortic valve replacement

Not Applicable

• Conditions: Severe symptomatic aortic stenosis; Circulatory System; Aortic (valve) stenosis

• Registration Number: ISRCTN64700462
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-15
• Last Update Posted: 30 March 2021
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

1. Able to provide written informed consent
2. Patients with symptomatic, severe AS referred for surgical or transcatheter AVR with one out of the following echocardiographic criteria for severe AS:
2.1. Effective orifice area [EOA] <1.0 cm²
2.2. Indexed EOA of 0.6 cm²/m²
2.3. Peak velocity >4.0 m/s or mean gradient >40 mmHg

Exclusion Criteria

1. More than moderate valve disease other than AS
2. Patients that have a conventional contraindication for CMR (non-MR conditional pacemakers/implantable defibrillators, claustrophobia)
3. Renal impairment (creatinine clearance <30 ml/min/1.73m²)
4. Needle phobic patients that would preclude blood taking
5. Diagnosis of dilated or hypertrophic cardiomyopathy
6. Pregnancy/breastfeeding, eGFR <30 ml/min
7. Inability to complete the protocol, other conditions that would prevent participation in the study.
8. Adenosine stress perfusion will not be performed in those patients with:
8.1. Asthma/COPD of sufficient severity to make adenosine contraindicated
8.2. High-grade conduction disease precluding the use of adenosine
8.3. Patients with known previous allergic reactions to adenosine
8.4. LVEF <40%

Study & Design

• Study Type: Observational
• Study Design: Not specified