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Mitral Valve Repair vs. MitraClip Implantation for Mitral Valve Regurgitation

Recruiting at77 trial locations
Patrick M. McCarthy, MD | Northwestern ...
Saibal Kar MD, Interventional ...
Overseen bySaibal Kar, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Abbott Medical Devices
Disqualifiers: Secondary MR, Tricuspid regurgitation, EF <30%, others
No Placebo Group

Trial Summary

What is the purpose of this trial?

The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the MitraClip treatment for mitral valve regurgitation?

The MitraClip system, including the new G4 device, has been shown to significantly reduce mitral regurgitation in patients who are not suitable for surgery, with over 3500 implants performed worldwide. It improves symptoms and quality of life in high-risk patients, making it an effective alternative to traditional surgery.12345

How is the MitraClip treatment different from other treatments for mitral valve regurgitation?

The MitraClip treatment is unique because it is a minimally invasive procedure that repairs the mitral valve without the need for open-heart surgery, making it suitable for patients who are at high risk for surgical procedures. The latest MitraClip G4 device offers new features and options that can better accommodate complex heart anatomies, potentially providing improved outcomes compared to older devices.12456

Research Team

Patrick M. McCarthy, MD | Northwestern ...

Patrick McCarthy, MD

Principal Investigator

Northwestern Memorial Hospital

Saibal Kar MD, Interventional ...

Saibal Kar, MD

Principal Investigator

Los Robles Regional Medical Center

ES

Erin Spinner, PhD

Principal Investigator

Abbott Structural Heart

Eligibility Criteria

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.

Inclusion Criteria

My heart surgeon agrees I can have mitral valve surgery and my valve is right for a specific clip procedure.
I have heart symptoms or my heart isn't pumping well.
I am 18 years old or older.
See 3 more

Exclusion Criteria

Your heart pumps less than 30% of the blood in it with each beat.
I am currently taking antibiotics for an infection.
Your mitral valve moves in a way that could cause problems with your heart.
See 15 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either MitraClip™ device implantation or mitral valve repair surgery

Up to 14 days
In-hospital stay for procedure and recovery

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years
Regular follow-up visits, including assessments at 30 days, 1 year, and 2 years

Long-term follow-up

Participants' quality of life and clinical outcomes are assessed over a 2-year period

2 years

Treatment Details

Interventions

  • MitraClip™ device implantation (Device)
  • Mitral Valve Repair Surgery (Procedure)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Device ArmExperimental Treatment1 Intervention
MitraClip™ device implantation
Group II: Control ArmExperimental Treatment1 Intervention
Mitral Valve Repair Surgery

MitraClip™ device implantation is already approved in Canada, Switzerland for the following indications:

🇨🇦
Approved in Canada as MitraClip for:
  • Primary mitral regurgitation (MR ≥ 3+)
  • Secondary (or functional) mitral regurgitation (MR ≥ Grade III)
🇨🇭
Approved in Switzerland as MitraClip for:
  • Primary mitral regurgitation (MR ≥ 3+)
  • Secondary (or functional) mitral regurgitation (MR ≥ Grade III)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Abbott Medical Devices

Lead Sponsor

Trials
659
Recruited
420,000+
Founded
1888
Headquarters
Abbott Park, Illinois, USA
Known For
Medical Devices Innovation
Top Products
FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs
Dr. Etahn Korngold profile image

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford profile image

Robert B. Ford

Abbott Medical Devices

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Findings from Research

The MitraClip G4 device has been successfully used in a patient with significant mitral regurgitation who was not a candidate for traditional surgery, resulting in a 57% reduction in mitral valve area, indicating its potential efficacy in challenging cases.
This is the first reported clinical use of the MitraClip G4 NTW device, suggesting it may offer better outcomes than previous devices while causing less reduction in mitral valve area, highlighting the need for further studies to refine patient selection.
First-in-human report of MitraClip G4 implantation for severe degenerative mitral regurgitation.Raghunathan, D., Garcia-Sayan, E., Dhoble, A., et al.[2021]
In a review of 26 cases using the MitraClip G4 device, the new clips (NTW and XTW) were utilized in a majority of cases, indicating their growing acceptance and potential effectiveness in treating mitral regurgitation.
The procedure significantly reduced the severity of mitral regurgitation from a median grade of 4+ to 1+, although some patients still experienced residual regurgitation, highlighting the need for ongoing evaluation of treatment outcomes.
Initial Experiences with the MitraClip G4: Review of the Novel Device Features.Ives, CW., Prejean, SP., Vardas, PN., et al.[2021]
The MitraClip system is the only catheter-based device approved for percutaneous mitral valve repair, with over 3500 implants performed globally, primarily in high-risk surgical patients.
This review aims to clarify the clinical role of MitraClip therapy in treating mitral regurgitation (MR), highlighting its significance in managing patients who may not be suitable for traditional surgery.
Review of the MitraClip clinical evidence.Maisano, F., Taramasso, M., Cioni, M., et al.[2012]

References

First-in-human report of MitraClip G4 implantation for severe degenerative mitral regurgitation. [2021]
Initial Experiences with the MitraClip G4: Review of the Novel Device Features. [2021]
Review of the MitraClip clinical evidence. [2012]
Percutaneous edge-to-edge repair of severe mitral regurgitation using the MitraClip XTR versus NTR system. [2021]
Quality of life following percutaneous mitral valve repair with the MitraClip System. [2015]
Comparison of transcatheter tricuspid valve repair using the MitraClip NTR and XTR systems. [2021]