Early Aortic vaLve surgEry Versus wAtchful waitiNg Strategy in Severe Asymptomatic aOrtic reguRgitation

NCT05438862 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2026-02-17

No results posted yet for this study

Summary

The optimal timing of surgical intervention in asymptomatic patients with severe aortic regurgitation remains controversial. As per cardiac magnetic resonance assessment, early surgical treatment will be compared with conventional guideline-based strategy in asymptomatic patients with severe aortic regurgitation.

Conditions

  • Aortic Valve Regurgitation

Interventions

PROCEDURE

State of art aortic valve surgery

Optimal surgical treatment (aortic valve-sparing surgery, aortic valve replacement, Ross procedure).

Sponsors & Collaborators

  • University Hospital Hradec Kralove

    collaborator OTHER
  • Centre of Cardiovascular and Transplantation Surgery, Czech Republic

    collaborator OTHER
  • St. Anne's University Hospital Brno, Czech Republic

    collaborator OTHER
  • VZW Cardiovascular Research Center Aalst

    collaborator OTHER
  • General University Hospital, Prague

    collaborator OTHER
  • University Clinical Centre of Republic of Srpska

    collaborator OTHER
  • AGEL Třinec-Podlesí Hospital

    collaborator UNKNOWN
  • Na Homolce Hospital

    lead OTHER

Principal Investigators

  • Radka Kočková, MD, PhD · Na Homolce Hospital

  • Jan Vojáček, MD, PhD · Faculty Hospital Hradec Králové

  • Martin Pěnička, MD, PhD · Cardiovascular Center OLV Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Belgium
  • Czechia
  • 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 NCT05438862 on ClinicalTrials.gov