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Clinical Trials/ISRCTN58128724
ISRCTN58128724
Completed
N/A

A pragmatic, prospective, randomised controlled trial comparing upper ministernotomy to full median sternotomy as a surgical approach for aortic valve replacement

Papworth Hospital NHS Foundation Trust (UK)0 sites222 target enrollmentJune 24, 2010
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ConditionsTopic: Cardiovascular, Generic Health Relevance and Cross Cutting ThemesSubtopic: Cardiovascular (all Subtopics), Generic Health Relevance (all Subtopics)Disease: Cardiovascular, SurgerySurgerySternotomy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Topic: Cardiovascular, Generic Health Relevance and Cross Cutting Themes
Sponsor
Papworth Hospital NHS Foundation Trust (UK)
Enrollment
222
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30075959 (added 01/10/2019)

Registry
who.int
Start Date
June 24, 2010
End Date
September 1, 2012
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Papworth Hospital NHS Foundation Trust (UK)

Eligibility Criteria

Inclusion Criteria

  • •1\. Aged greater than 18 years at the time of surgery, either sex
  • •2\. Elective, first time, isolated aortic valve replacement (AVR)

Exclusion Criteria

  • •1\. Documented poor left ventricular (LV) function or left ventricular ejection fraction (LVEF) 30%
  • •2\. Documented chest wall deformities
  • •3\. Documented severe emphysema or chronic obstructive pulmonary disease (COPD)
  • •4\. Current body mass index (BMI) greater than 35 kg/m^2
  • •5\. Concomitant cardiac surgery
  • •6\. Redo surgery
  • •7\. Median sternotomy indicated

Outcomes

Primary Outcomes

Not specified

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