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Treatment algorithm for Mitral Valve Regurgitation

N/A
Waitlist Available
Led By Vincent Chan, MD
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Severe ischemic mitral valve regurgitation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after surgery
Awards & highlights

Study Summary

This trialtests if a specific method of deciding whether to repair or replace the mitral valve can improve outcomes in IMR.

Who is the study for?
This trial is for adults who can consent and have severe ischemic mitral valve regurgitation, a heart condition where the valve leaks due to coronary artery disease. It's not for those with mixed valve issues or acute cases of this condition.Check my eligibility
What is being tested?
The study compares two approaches: one group gets standard care (valve repair/replacement based on surgeon choice), while the other follows a treatment algorithm deciding between repair or replacement based on specific measurements of the mitral valve.See study design
What are the potential side effects?
Since this trial involves surgical procedures, potential side effects include typical surgery risks such as infection, bleeding, reactions to anesthesia, and complications related to heart surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have severe leakage in my heart's mitral valve due to poor blood supply.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Left ventricle end-systolic volume indexed to body surface area
Secondary outcome measures
Change in indexed left atrial volume
Change in right ventricle systolic pressure
Major adverse events

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment algorithmExperimental Treatment1 Intervention
Mitral valve will be replaced if posterior leaflet tethering angle >=25 degrees. Mitral valve will be repaired if posterior leaflet tethering angle <25 degrees
Group II: No treatment algorithmActive Control1 Intervention
Mitral valve will be repaired or replaced at surgeon's discretion.

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,326 Total Patients Enrolled
Vincent Chan, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation
10 Previous Clinical Trials
1,123 Total Patients Enrolled

Media Library

Treatment Algorithm Clinical Trial Eligibility Overview. Trial Name: NCT03292497 — N/A
Mitral Valve Regurgitation Research Study Groups: Treatment algorithm, No treatment algorithm
Mitral Valve Regurgitation Clinical Trial 2023: Treatment Algorithm Highlights & Side Effects. Trial Name: NCT03292497 — N/A
Treatment Algorithm 2023 Treatment Timeline for Medical Study. Trial Name: NCT03292497 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently recruiting participants?

"Derived from clinicaltrials.gov, this research is not accepting any more volunteers at the present moment. The first posting was on January 16th 2018 and it has seen its latest update on March 25th 2021. Nevertheless, 103 other trials are looking for participants now."

Answered by AI
~46 spots leftby Nov 2028