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Medical Versus Surgical Management of Moderate Mitral Regurgitation Following Percutaneous Coronary Intervention

NCT01156441 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2014-06-16

No results posted yet for this study

Summary

The pilot prospective randomized trial is designed to determine the safety and feasibility of enrolling patients to surgically correct residual Mitral Regurgitation (MR) following Percutaneous Coronary Intervention (PCI) for Myocardial Infarction (MI) verses ongoing medical management of MR. The investigators hypothesize that if moderate MR is corrected in this patient subset, the patients will have improved outcomes as measured by decreased number of major adverse cardiac events, including death, congestive heart failure requiring hospitalization, atrial fibrillation, deterioration of New York Heart Association (NYHA) functional status and improved quality of life.

Conditions

Interventions

PROCEDURE

surgical mitral valve repair w/ mitral valve annuloplasty

Mitral valve repair will be performed via median sternotomy, utilizing cardiopulmonary bypass and moderate hypothermia. The mitral valve will be approached through a left atrial incision. Following inspection of the valve, mitral valve annuloplasty will be accomplished with a complete semi-rigid annuloplasty ring. Additional techniques to address residual regurgitation will be at the discretion of the surgeon. The left atriotomy will then be closed and the patient weaned off and separated from the cardiopulmonary bypass. Intraoperative transesophageal echocardiography will be performed on all study volunteers.

Sponsors & Collaborators

  • Southern Illinois University

    lead OTHER

Principal Investigators

  • Christina Vassileva, M.D. · Southern Illinois University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01156441 on ClinicalTrials.gov