Mitral Valve Repair vs. MitraClip Implantation for Mitral Valve Regurgitation

Not currently recruiting at 96 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for individuals with severe mitral valve regurgitation, a condition where the heart's mitral valve doesn't close properly, causing blood to flow backward. One group will receive the MitraClip™ device, a less invasive procedure, while the other will undergo traditional mitral valve repair surgery. It is suitable for those experiencing symptoms of severe mitral valve regurgitation and whose doctors have recommended surgery as an option. Participants should be at moderate risk for surgery, meaning they have some health factors that make surgery more complicated but still feasible. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for mitral valve regurgitation.

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 prior data suggests that the MitraClip™ device and Mitral Valve Repair Surgery are safe for treating mitral valve regurgitation?

Research has shown that the MitraClip™ device is generally safe for patients. In a study with over 1,000 patients, more than 90% experienced a noticeable improvement in their mitral regurgitation (MR) within a year, indicating better heart valve function with few problems. Another study found that the MitraClip system reduced MR in everyday settings, demonstrating its effectiveness and practicality for regular use. These studies report that the treatment is well-tolerated, with no major safety concerns.

Mitral Valve Repair Surgery, while common and generally safe for treating MR, is more invasive than the MitraClip device. Both treatments have been successful, but patients should discuss the possible risks and benefits with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the MitraClip™ device implantation for mitral valve regurgitation because it offers a less invasive alternative to traditional open-heart mitral valve repair surgery. Unlike surgery, which involves opening the chest and stopping the heart, the MitraClip is delivered via a catheter inserted through a vein, making it a less risky option for patients who may not be candidates for surgery. This device works by clipping together a portion of the mitral valve leaflets to reduce regurgitation, which can lead to improved heart function and symptom relief. The potential for a quicker recovery time and fewer complications makes the MitraClip an appealing option for both patients and doctors.

What evidence suggests that this trial's treatments could be effective for mitral valve regurgitation?

This trial will compare Mitral Valve Repair Surgery with MitraClip™ device implantation for treating mitral valve regurgitation. Research has shown that the MitraClip device effectively treats this condition, which occurs when the heart's mitral valve doesn't close properly, causing blood to leak backward. Studies indicate that the MitraClip reduces the severity of this condition in over 90% of patients after one year. The device has shown positive results even in patients with more complex health issues. Clinical data from the EXPAND study confirmed significant improvement in mitral valve function with the MitraClip in real-world use. Overall, the MitraClip has proven to be a safe and effective option for managing this heart condition. ^{1 2 3 6 7}

Who Is on the Research Team?

Patrick McCarthy, MD

Principal Investigator

Northwestern Memorial Hospital

Saibal Kar, MD

Principal Investigator

Los Robles Regional Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38598251/

Transcatheter mitral valve repair with MitraClip Conclusions: New-generation MitraClip devices are associated with favorable procedural and clinical outcomes, despite being used in patients with more adverse ...

2. mitraclip.com mitraclip.com/physician/mitraclip-procedure/mitraclip-features

MitraClip G4 Features - Tailored. Optimized. Proven. Contemporary Clinical Outcomes with MitraClip™ (NTR/XTR) System: Core-lab Echo Results from +1000 Patient the Global EXPAND Study. Data presented at PCR 2020.

3. jacc.org jacc.org/doi/10.1016/j.jcin.2023.09.029

1-Year Outcomes With Fourth-Generation Mitral Valve ... M-TEER with the fourth-generation M-TEER device was safe and effective at 1 year, with durable reductions in MR severity to ≤1+ in more than 90% of patients.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1936879823000109

1-Year Results From the EXPAND Study ... The study demonstrates treatment with the third-generation system resulted in substantial reduction of MR in a contemporary real-world practice.

5. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.027504

Percutaneous MitraClip Device or Surgical Mitral Valve ... Outcomes with the MitraClip system have been recently reported in both single‐center and multicenter studies, with >90% experiencing an MR ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8119798/

Percutaneous edge‐to‐edge repair of severe mitral ... This study systematically analyses and compares the efficacy and safety of two MitraClip‐devices, the MitraClip XTR and NTR system. While both devices ...

7. mitraclip.com mitraclip.com/physician/safety/mitraclip-expand-study

MitraClip EXPAND Study | Mitral Regurgitation Reduction The EXPAND study reported the highest ECL adjudicated MR reduction to date with 89% of patients with MR <=1+ at 1 year.