MitraClip™ device implantation for Mitral Valve Regurgitation

Phase-Based Progress Estimates
University Hospital - Univiversity of Alabama at Birmingham, Birmingham, ALMitral Valve RegurgitationMitraClip™ device implantation - Device
All Sexes
What conditions do you have?

Study Summary

This trial is comparing the effectiveness of two treatments for severe primary MR in patients who are at moderate surgical risk.

Eligible Conditions
  • Mitral Valve Regurgitation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 2 Years

1 Year
Severe symptomatic mitral stenosis at 1 year
2 Years
All-cause mortality, stroke, cardiac hospitalization, or acute kidney injury requiring renal replacement therapy at 2 years (any cardiac hospitalizations in the first 30 days post treatment will be excluded)
Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous)
Quality of life improvement assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) of at least 10 points at 2 years compared to baseline among survivors.
30 Days
Proportion of subjects with MR ≤ mild at 30 days post index procedure among survivors
Day 14
Number of days at hospital from index procedure to home discharge
Proportion of subjects discharged to home post index hospitalization

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Device Arm
1 of 1

Experimental Treatment

500 Total Participants · 1 Treatment Group

Primary Treatment: MitraClip™ device implantation · No Placebo Group · N/A

Device Arm
Experimental Group · 1 Intervention: MitraClip™ device implantation · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
601 Previous Clinical Trials
364,821 Total Patients Enrolled
Kartik Sundareswaran, PhDStudy DirectorAbbott Structural Heart
5 Previous Clinical Trials
3,033 Total Patients Enrolled
Patrick McCarthy, MDPrincipal InvestigatorNorthwestern Memorial Hospital
2 Previous Clinical Trials
405 Total Patients Enrolled
Saibal Kar, MDPrincipal InvestigatorLos Robles Regional Medical Center
4 Previous Clinical Trials
3,708 Total Patients Enrolled
Erin Spinner, PhDStudy DirectorAbbott Structural Heart
1 Previous Clinical Trials
700 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

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Frequently Asked Questions

Where in North America are trials being conducted involving this clinical research?

"For this clinical trial, 57 sites are operating. Selected locations include the Lankenau Institute for Medical Research in Wynnewood, Sentara Norfolk General Hospital in Norfolk, and University Hospitals Cleveland Medical Center in Cleveland." - Anonymous Online Contributor

Unverified Answer

Is the enrollment period for this research still open?

"Affirmative. Per the database, this research project is actively recruiting participants at 57 different medical centres. The investigation was posted on July 21st 2020 and was recently refreshed on October 31st 2022 with 500 total patients needed for enrollment." - Anonymous Online Contributor

Unverified Answer

How many participants are being recruited for this medical experiment?

"This clinical trial requires 500 qualified participants, who meet the criteria for inclusion. The medical centres hosting this study are Lankenau Institute for Medical Research in Wynnewood, Pennsylvania and Sentara Norfolk General Hospital in Norfolk, Virginia." - Anonymous Online Contributor

Unverified Answer

What are the primary aims of this medical trial?

"According to Abbott Medical Devices, the clinical trial's principal aim is a 2-year evaluation of all-cause mortality, stroke risk, cardiac hospitalization events or acute kidney injury necessitating renal replacement therapy (excluding any cardiac episodes within 30 days post treatment). Additionally, this study will also assess secondary endpoints such as severe symptomatic mitral stenosis at 1 year and time spent in care from index procedure to home discharge for both Device and Control groups. Lastly, investigators are looking into the proportion of patients being discharged to their homes after treatment amongst both experimental arms." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.