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The Dutch Asymptomatic Mitral Regurgitation Trial

NCT01708265 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-11-23

No results posted yet for this study

Summary

The purpose of this study is to compare early mitral valve repair versus a watchful waiting strategy in asymptomatic patients with severe organic mitral valve regurgitation and preserved left ventricular function.

Conditions

  • Heart; Disease, Mitral(Valve)
  • Diseases of Mitral Valve
  • Mitral Valve Insufficiency

Interventions

OTHER

Watchful waiting

In case of watchful waiting a conservative treatment is performed, based on close monitoring of the patient for clear signs of deterioration that triggers facilitated surgery before left ventricular dysfunction is present.

PROCEDURE

Early mitral valve repair

Patients in the group of early mitral valve repair will be operated by way of routine mitral valve repair procedures in specialized centres.

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER

  • The Interuniversity Cardiology Institute of the Netherlands

    collaborator OTHER_GOV

  • WCN, Dutch Network for Cardiovascular Research

    collaborator UNKNOWN

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Steven AJ Chamuleau, MD, PhD · University Medical Center Utrecht (UMC Utrecht)

  • Jolanda Kluin, MD, PhD · University Medical Center Utrecht (UMC Utrecht)

  • Robert JM Klautz, Prof. MD PhD · Leiden University Medical Center (LUMC Leiden)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • Netherlands

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 NCT01708265 on ClinicalTrials.gov