CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02841917
NCT02841917N/ACompleted

Oxidative Stress Response in Patients With Severe Aortic Stenosis Undergoing Transcatheter or Surgical Aortic Valve Replacement (ROS Study)

University Hospital Southampton NHS Foundation Trust·observational·Posted Jul 22, 2016·Updated Sep 6, 2018

In Brief

An observational study for Aortic Stenosis. Completed, enrolled 3 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Stenosis
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJul 22, 2016
Enrollment StartNov 29, 2016
Primary CompletionMar 31, 2017
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 9.9 years ago