Mitral Valve Repair vs. MitraClip Implantation for Mitral Valve Regurgitation

Recruiting at 77 trial locations

Overseen By Diana Posa Podean

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Disqualifiers: Secondary MR, Tricuspid regurgitation, EF <30%, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

Duration: Up to 14 days

500 Participants Needed

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}

Research Team

Patrick McCarthy, MD

Principal Investigator

Northwestern Memorial Hospital

Saibal Kar, MD

Principal Investigator

Los Robles Regional Medical Center

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 have severe mitral valve regurgitation.

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.

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
• Mitral Valve Repair Surgery

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, 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 Switzerland as MitraClip for:

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

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

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the MitraClip clinical evidence. Maisano, F., Taramasso, M., Cioni, M., et al.[2012]

In a study of 113 patients with severe mitral valve regurgitation, both the MitraClip XTR and NTR systems effectively reduced MR to ≤2+, showing similar efficacy in improving symptoms and functional capacity.

However, the MitraClip XTR system was associated with a significantly higher risk of leaflet injury, with 14.6% of patients experiencing major adverse cardiac and cerebrovascular events compared to only 1.7% in the NTR group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous edge-to-edge repair of severe mitral regurgitation using the MitraClip XTR versus NTR system. Doldi, PM., Brinkmann, I., Orban, M., et al.[2021]

In a study of 39 patients with severe mitral regurgitation, the MitraClip System achieved a 100% procedural success rate, with 86% of patients showing mild or no mitral regurgitation at 6 months follow-up.

Patients reported significant improvements in quality of life, with physical health scores increasing from 35.44 to 44.67 and mental health scores from 38.07 to 46.94, indicating that the procedure effectively enhances both physical and mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life following percutaneous mitral valve repair with the MitraClip System. Ussia, GP., Cammalleri, V., Sarkar, K., et al.[2015]

In a study of 40 patients with severe tricuspid regurgitation (TR), both the MitraClip NTR and XTR systems were found to be safe and effective for transcatheter tricuspid leaflet repair, achieving procedural success rates of 70% and 80%, respectively.

The XTR system demonstrated superior efficacy, achieving a greater mean reduction in TR grade and effectively treating larger coaptation gaps, with 55% of patients with torrential TR reducing their TR to ≤2+ compared to none in the NTR group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of transcatheter tricuspid valve repair using the MitraClip NTR and XTR systems. Ali, FM., Ong, G., Edwards, J., et al.[2021]

References

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

First-in-human report of MitraClip G4 implantation for severe degenerative mitral regurgitation. [2021]

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

Initial Experiences with the MitraClip G4: Review of the Novel Device Features. [2021]

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

Review of the MitraClip clinical evidence. [2012]

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]

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

Quality of life following percutaneous mitral valve repair with the MitraClip System. [2015]

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

Comparison of transcatheter tricuspid valve repair using the MitraClip NTR and XTR systems. [2021]