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Clinical Trials/ISRCTN64700462
ISRCTN64700462
Active, not recruiting
未知

Mechanisms of excess risk in aortic stenosis after aortic valve replacement: a prospective single-centre observational cohort study

niversity College London0 sites192 target enrollmentMarch 15, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
Severe symptomatic aortic stenosis
Sponsor
niversity College London
Enrollment
192
Status
Active, not recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 15, 2021
End Date
April 1, 2026
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
niversity College London

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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