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Device

Mitral Valve Repair vs. MitraClip Implantation for Mitral Valve Regurgitation

N/A

Recruiting

Led By Patrick McCarthy, MD

Research Sponsored by Abbott Medical Devices

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The cardiac surgeon of the Site Heart Team has confirmed that the subject is a candidate for mitral valve surgery and the EC have confirmed that the subject's mitral valve anatomy is suitable for percutaneous repair with the MitraClip™ device with high certainty of achieving MR ≤ mild

Subject is ≥ 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

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

Who is the study for?

This trial is for adults with severe primary mitral valve regurgitation who are at moderate surgical risk. Candidates must be suitable for both MitraClip device implantation and surgery, as confirmed by a heart team. They may have symptoms or certain heart function measurements that indicate treatment is needed. People with active infections, renal failure on dialysis, severe mitral annular calcification, or those needing other cardiac surgeries are excluded.Check my eligibility

What is being tested?

The study compares the MitraClip device implantation to traditional surgical repair in patients with severe primary mitral valve regurgitation. It's a randomized controlled trial where participants will be assigned to one of these treatments based on chance.See study design

What are the potential side effects?

Potential side effects can include complications from the procedure like bleeding or infection, issues related to heart function changes post-treatment, and general risks associated with any invasive cardiac procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart surgeon agrees I can have mitral valve surgery and my valve is right for a specific clip procedure.

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I am 18 years old or older.

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I have severe mitral valve regurgitation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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)

Secondary outcome measures

Number of days at hospital from index procedure to home discharge

Proportion of subjects discharged to home post index hospitalization

Proportion of subjects with MR ≤ mild at 30 days post index procedure among survivors

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Device ArmExperimental Treatment1 Intervention

MitraClip™ device implantation

Group II: Control ArmExperimental Treatment1 Intervention

Mitral Valve Repair Surgery

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor

638 Previous Clinical Trials

403,995 Total Patients Enrolled

Kartik Sundareswaran, PhDStudy DirectorAbbott Structural Heart

5 Previous Clinical Trials

2,905 Total Patients Enrolled

Patrick McCarthy, MDPrincipal InvestigatorNorthwestern Memorial Hospital

2 Previous Clinical Trials

405 Total Patients Enrolled

Media Library

MitraClip™ device implantation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04198870 — N/A

Mitral Valve Regurgitation Research Study Groups: Control Arm, Device Arm

Mitral Valve Regurgitation Clinical Trial 2023: MitraClip™ device implantation Highlights & Side Effects. Trial Name: NCT04198870 — N/A

MitraClip™ device implantation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04198870 — N/A

Frequently Asked Questions

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

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."

Answered by AI

Is the enrollment period for this research still open?

"Affirmative. Per the clinicaltrials.gov 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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

JACC: Cardiovascular InterventionsJournal

Mitral Valve Surgery After Transcatheter Edge-to-edge Repair

Kaneko, Tsuyoshi, Sameer Hirji, Syed Zaid, Rudiger Lange, Jörg Kempfert, Lenard Conradi, Christian Hagl, et al.. 2021. “Mitral Valve Surgery After Transcatheter Edge-to-edge Repair”. JACC: Cardiovascular Interventions. Elsevier BV. doi:10.1016/j.jcin.2021.07.029.

clinicaltrials.govStudy

MitraClip REPAIR MR Study

2020. "MitraClip REPAIR MR Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04198870.