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Reactive Oxygen Species Following Aortic Valve Replacement

NCT02841917 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2018-09-06

No results posted yet for this study

Summary

Surgical aortic valve replacement (SVAR) is currently the 'Gold Standard' therapy for patients with severe symptomatic aortic stenosis (AS). Approximately 30-50% of patients with severe AS are deemed inoperable due to comorbidities such as severe respiratory disease, chronic renal disease and peripheral vascular disease. Transcatheter aortic valve replacement (TAVR) has emerged as a novel therapeutic modality for inoperable patients and an effective alternative to SAVR in selected high and intermediate-risk patients. Myocardial ischemia and reperfusion injury (MRI), mediated by reactive oxygen species (ROS), related to cardiopulmonary bypass has been linked to adverse clinical outcomes following cardiac surgery. In contrast to SAVR, transcatheter deployment of aortic prostheses requires shorter time of ischemia and hypotension and may be associated with less ROS mediated MRI. Inflammatory responses and reperfusion injury following TAVR have not been previously described nor compared to SAVR. The aim of this study is therefore to compare the oxidative stress response in patients with isolated severe symptomatic AS undergoing SAVR or TAVR and determine whether it correlates with clinical outcomes.

Conditions

  • Aortic Stenosis

Sponsors & Collaborators

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Michael Mahmoudi, MD,PhD · University Hospital Southampton NHS Foundation Trust

  • Gabriel Maluenda, MD · Centro Cardiovascular, Hospital San Borja, Chile

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-29
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02841917 on ClinicalTrials.gov