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Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis

NCT02436655 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2022-01-12

No results posted yet for this study

Summary

Whether to intervene in asymptomatic patients with severe aortic stenosis and normal left ventricular ejection fraction remains controversial. The investigators therefore try to compare clinical outcomes of elective aortic valve replacement to conventional treatment and watchful waiting strategy in a prospective randomized trial.

Conditions

  • Aortic Stenosis

Interventions

PROCEDURE

surgical aortic valve replacement

open heart aortic valve replacement

Sponsors & Collaborators

  • Clinical Centre of Serbia

    lead OTHER

Principal Investigators

  • Marko Banovic, MD, PhD, FESC, FACC · Cardiology Department, University Clinical Centre of Serbia

  • Svetozar Putnik, MD, PhD · Cardiac Surgery Department, University Clinical Centre of Serbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • Belgium
  • Croatia
  • Czechia
  • France
  • Ireland
  • Italy
  • Lithuania
  • Poland
  • Serbia

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 NCT02436655 on ClinicalTrials.gov