Mitral Valve Repair vs. MitraClip Implantation for Mitral Valve Regurgitation

Recruiting in Palo Alto (17 mi)

+77 other locations

Overseen by Patrick McCarthy, 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. ^{1 2 3 4 5}

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. ^{1 2 4 5 6}

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.

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.

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 Overview 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.

Participant Groups

Group I: Device Arm Experimental Treatment 1 Intervention

MitraClip™ device implantation

Group II: Control Arm Experimental Treatment 1 Intervention

Mitral Valve Repair Surgery

MitraClip™ device implantation is already approved in United States, European Union, Canada, Australia, Switzerland for the following indications:

🇺🇸 Approved in United States as MitraClip for:

• Primary mitral regurgitation (MR ≥ 3+)
• Secondary (or functional) mitral regurgitation (MR ≥ Grade III)

🇪🇺 Approved in European Union as MitraClip for:

• Primary mitral regurgitation (MR ≥ 3+)
• Secondary (or functional) mitral regurgitation (MR ≥ Grade III)

🇨🇦 Approved in Canada as MitraClip for:

• Primary mitral regurgitation (MR ≥ 3+)
• Secondary (or functional) mitral regurgitation (MR ≥ Grade III)

🇦🇺 Approved in Australia 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

Research Locations Nearby Select from list below to view details:

UC Davis Medical Center Sacramento, CA

Saint Joseph Hospital Denver, CO

NCH Healthcare System Naples, FL

Yale New Haven Hospital New Haven, CT

More Trial Locations

Who Is Running the Clinical Trial?

Abbott Medical Devices Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

First-in-human report of MitraClip G4 implantation for severe degenerative mitral regurgitation. [2021] The new MitraClip G4 device (Abbott Vascular) has been recently approved by Food and Drug Administration and is currently in limited release. A patient with a large mitral regurgitation (MR) jet but a relatively small mitral valve area (MVA) was not a surgical repair candidate nor an optimal MitraClip third-generation device candidate. Therefore, we implanted the new G4 NTW device that resulted in significant MR reduction with a 57% reduction in MVA. To our knowledge, this is the first reported clinical use of the MitraClip G4 NTW device. We find that it may provide better results than a single NTR device and less reduction in MVA than two older generation devices. Further experience is needed to optimize patient selection for the four new G4 devices available.

2. United States pubmed.ncbi.nlm.nih.gov

Initial Experiences with the MitraClip G4: Review of the Novel Device Features. [2021] Percutaneous edge-to-edge mitral valve repair is an evolving procedure with increasing indications for use. The MitraClip™ G4 is the newest device with 4 device options, each with distinct characteristics. While the NTR and XTR clips have been in use, the G4 adds 2 new wider clips with additional features, the NTW and XTW.

3. Italy pubmed.ncbi.nlm.nih.gov

Review of the MitraClip clinical evidence. [2012] MitraClip system is the only catheter-based device for percutaneous mitral valve repair available for clinical use, after receipt of the CE Mark in 2008, while it is currently under review for FDA approval in the US. To date, over 3500 MitraClip implants have been performed worldwide, mainly in high risk surgical patients. The aim of this review is to review all the current evidences of the MitraClip therapy in an aim to define its clinical role in the treatment of mitral regurgitation (MR).

4. United States pubmed.ncbi.nlm.nih.gov

Percutaneous edge-to-edge repair of severe mitral regurgitation using the MitraClip XTR versus NTR system. [2021] Transcatheter mitral valve repair (TMVR) has shown to improve symptoms and functional capacity in patients with severe mitral valve regurgitation (MR). Novel device developments provide the technology to treat patients with complex anatomies and large coaptation gaps. Nevertheless, the question of superiority of one device remains unanswered. We aimed to compare the MitraClip XTR and MitraClip NTR system in a real world setting.

5. Netherlands pubmed.ncbi.nlm.nih.gov

Quality of life following percutaneous mitral valve repair with the MitraClip System. [2015] Percutaneous valve repair with MitraClip System is an emerging alternative for high surgical risk patients with severe mitral regurgitation (MR). QoL is a critical measure of effectiveness of this procedure. We sought to evaluate quality of life (QoL) and NYHA class following this novel procedure.

6. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of transcatheter tricuspid valve repair using the MitraClip NTR and XTR systems. [2021] Transcatheter tricuspid leaflet repair (TTVr) using the MitraClip is a promising option for patients with severe tricuspid regurgitation (TR) and heart failure. However, no comparative studies of the NTR and XTR systems have been reported.