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Heart Valve Replacement

SAPIEN M3 System for Mitral Valve Regurgitation (ENCIRCLE Trial)

N/A
Recruiting
Led By John Webb, MD
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
NYHA functional class ≥ II
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

ENCIRCLE Trial Summary

This trial will study a new treatment for people with MR who can't have surgery or current transcatheter options.

Who is the study for?
The ENCIRCLE Trial is for adults with severe mitral valve regurgitation who can't have standard surgery or other transcatheter treatments. They must be stable after heart failure management and not pregnant, in another trial, or have conditions like recent heart attacks, untreated coronary disease, certain anatomy issues, severe lung problems, or life expectancy under a year.Check my eligibility
What is being tested?
This study tests the SAPIEN M3 System's safety and effectiveness for patients with symptomatic mitral regurgitation deemed unsuitable for other treatments. Participants will receive the SAPIEN M3 valve and dock to correct their condition.See study design
What are the potential side effects?
While specific side effects are not listed here, similar procedures may include risks such as bleeding, infection at the catheter insertion site, damage to blood vessels or the heart itself during implantation of the device.

ENCIRCLE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have some limitations on physical activity due to heart problems.

ENCIRCLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Non-hierarchical composite of death and heart failure rehospitalization
Secondary outcome measures
Decrease in LVEDVi compared to baseline
Improvement in KCCQ Overall Score compared to baseline
Improvement in MR compared to baseline
+1 more

ENCIRCLE Trial Design

3Treatment groups
Experimental Treatment
Group I: TMVR - Main CohortExperimental Treatment1 Intervention
Subjects for whom commercially available surgical or transcatheter treatment options are deemed unsuitable will have transcatheter mitral valve replacement (TMVR).
Group II: TMVR - MAC RegistryExperimental Treatment1 Intervention
Subjects with mitral annular calcification (MAC) will have TMVR.
Group III: TMVR - Failed TEER RegistryExperimental Treatment1 Intervention
Subjects who have had an attempted but failed transcatheter edge-to-edge repair (TEER) procedure will have TMVR.

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
60,674 Total Patients Enrolled
John Webb, MDPrincipal InvestigatorSt. Paul's Hospital
5 Previous Clinical Trials
727 Total Patients Enrolled
Mayra Guerrero, MDPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
398 Total Patients Enrolled

Media Library

SAPIEN M3 System (Heart Valve Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT04153292 — N/A
Mitral Valve Regurgitation Research Study Groups: TMVR - Main Cohort, TMVR - MAC Registry, TMVR - Failed TEER Registry
Mitral Valve Regurgitation Clinical Trial 2023: SAPIEN M3 System Highlights & Side Effects. Trial Name: NCT04153292 — N/A
SAPIEN M3 System (Heart Valve Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04153292 — N/A
Mitral Valve Regurgitation Patient Testimony for trial: Trial Name: NCT04153292 — N/A

Frequently Asked Questions

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

Are there currently any openings in this clinical trial?

"As documented in clinicaltrials.gov, this experiment is currently accepting volunteers. The trial was started on November 12th 2020 and the most recent update took place on November 23rd 2022."

Answered by AI

Are multiple facilities conducting this investigation in the local area?

"At the present moment, this clinical trial has established 53 sites across multiple cities; including Orange, Cincinnati and Phoenix. To reduce any potential travelling expenses, it is advised to select a nearby site if you decide to join the study."

Answered by AI

How many individuals are being observed in this investigation?

"That is correct. Per the information hosted on clinicaltrials.gov, this medical trial is searching for 500 patients across 53 different sites and has been posted since November 12th 2020 with its most recent update being on November 23rd 2022."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
What site did they apply to?
St. Vincent Heart Center of Indiana
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I've had a mitral valve clip procedure that has made me worse. I'm 53 and would Like to improve my quality of life.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
The ENCIRCLE Trial
2020. "The ENCIRCLE Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04153292.
~401 spots leftby Feb 2027
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