Percutaneous vs Surgical Repair for Mitral Valve Regurgitation

(PRIMARY Trial)

Recruiting in Palo Alto (17 mi)

+45 other locations

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Annetine Gelijns

Must not be taking: Investigational drugs

Disqualifiers: Non-degenerative MR, Cardiomyopathy, CAD, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation (MR). The trial will be conducted in the U.S., Canada, Germany and the United Kingdom, and is designed as a strategy trial. Thus, all devices legally marketed for TEER of primary degenerative MR in a particular country are eligible to be used in this trial.

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 coordinators or your healthcare provider.

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

Research shows that transcatheter edge-to-edge repair (TEER) is an effective treatment for mitral valve regurgitation, providing symptom relief and improved outcomes, especially for patients who are not suitable for open heart surgery. ^{1 2 3 4 5}

Is transcatheter edge-to-edge repair (TEER) for mitral valve regurgitation safe?

TEER, including the MitraClip system, is generally considered safe for treating mitral valve regurgitation, with studies showing it as a less invasive option for patients. However, there may be a need for further surgical intervention in some cases, and safety data is still being gathered. ^{1 3 4 6 7}

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

Mitral valve TEER (Transcatheter Edge-to-Edge Repair) is unique because it is a less invasive procedure compared to traditional open-heart surgery, making it suitable for patients who are at high risk for surgical complications. It involves using a device like the MitraClip to repair the valve through a catheter, which is inserted through a small incision, reducing recovery time and hospital stay. ^{1 3 4 6 8}

Eligibility Criteria

This trial is for adults aged 65 or older with a specific heart valve condition called primary degenerative mitral regurgitation. Candidates must be able to perform physical tests and complete health questionnaires, and are eligible across all surgical risk levels. Exclusions include recent febrile illness, need for other heart surgeries, certain allergic reactions, bleeding disorders, prior mitral interventions, and severe co-existing conditions.

Inclusion Criteria

If you have atrial fibrillation and need both catheter-based and surgical ablation, your local heart team must confirm that you are eligible for both procedures.

I am 65 or older with severe valve leakage as shown by an echo test.

My heart condition is considered low, intermediate, or high risk by my medical team.

Exclusion Criteria

You might not be able to keep up with the required check-ups and appointments.

I have a thickened heart muscle that obstructs blood flow.

You have secondary or functional mitral regurgitation.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either mitral valve transcatheter edge-to-edge repair (TEER) or surgical repair

1 month

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Annual visits (in-person)

Long-term follow-up

Participants are followed for up to 10 years post intervention for particular endpoints

10 years

Treatment Details

Interventions

• Mitral valve repair (Procedure)
• TEER (Device)

Trial Overview The PRIMARY trial compares two treatments for mitral valve prolapse: a less invasive procedure called transcatheter edge-to-edge repair (TEER) versus traditional surgery. Participants will be randomly assigned to one of the two options in equal numbers at multiple centers internationally.

Participant Groups

Group I: Surgical mitral valve repair Active Control 1 Intervention

Patients who are randomized to the surgical arm will undergo mitral surgery.

Group II: Transcatheter edge-to-edge repair Active Control 1 Intervention

In the transcatheter edge-to-edge repair arm, patients will be treated with a commercially-approved edge-to-edge mitral repair device.

Mitral valve repair is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as MitraClip for:

• Primary degenerative mitral regurgitation
• Secondary mitral regurgitation in heart failure patients

🇪🇺 Approved in European Union as MitraClip for:

• Primary degenerative mitral regurgitation
• Secondary mitral regurgitation in heart failure patients

🇨🇦 Approved in Canada as MitraClip for:

• Primary degenerative mitral regurgitation
• Secondary mitral regurgitation in heart failure patients

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

West Virginia University Hospital Morgantown, WV

Emory University Atlanta, GA

Cleveland Clinic Cleveland, OH

Baylor, Scott and White Dallas, TX

More Trial Locations

Who Is Running the Clinical Trial?

Annetine Gelijns Lead Sponsor

National Heart, Lung, and Blood Institute (NHLBI) Collaborator

References

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

Three-year outcomes for transcatheter repair in patients with mitral regurgitation from the CLASP study. [2023] Mitral valve transcatheter edge-to-edge repair (M-TEER) is an effective option for treatment of mitral regurgitation (MR). We previously reported favorable 2-year outcomes for the PASCAL transcatheter valve repair system.

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

Outcomes Stratified by Adapted Inclusion Criteria After Mitral Edge-to-Edge Repair. [2022] Although mitral valve transcatheter edge-to-edge repair (M-TEER) achieves symptomatic benefit for a broad spectrum of patients with relevant secondary mitral regurgitation, conflicting data exist on its prognostic impact.

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

Short-Term Outcomes Following Transcatheter Edge-to-Edge Repair: Insights From the OCEAN-Mitral Registry. [2023] Transcatheter edge-to-edge repair (TEER) is a less invasive treatment for patients with mitral regurgitation (MR). Limited safety and efficacy data of TEER with MitraClip, including the fourth-generation (G4) system, in a large cohort, are available.

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

Outcomes After Transcatheter Edge-to-Edge Mitral Valve Repair According to Mitral Regurgitation Etiology and Cardiac Remodeling. [2022] Transcatheter edge-to-edge repair (TEER) has been increasingly used for selected patients with mitral regurgitation (MR), but limited data are available regarding clinical outcomes in patients with varied etiology and mechanism of MR.

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

Surgical Removal of a Detached Mitral Valve Repair Clip to Resolve Cardiogenic Shock. [2022] Transcatheter edge-to-edge mitral valve repair (TEER) with a clip device relieves symptoms and improves outcomes in patients not suitable for open heart surgery. Here, we present a patient in whom ventricular arrhythmias developed as a result of clip embolization shortly after TEER. He underwent successful emergent surgical clip removal and mitral valve replacement. (Level of Difficulty: Advanced.).

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

Mitral Surgery After Transcatheter Edge-to-Edge Repair: Society of Thoracic Surgeons Database Analysis. [2022] Transcatheter edge-to-edge (TEER) mitral repair may be complicated by residual or recurrent mitral regurgitation. An increasing need for surgical reintervention has been reported, but operative outcomes are ill defined.

7. Poland pubmed.ncbi.nlm.nih.gov

Transcatheter edge-to-edge mitral valve repair in patients with acute decompensated heart failure due to severe mitral regurgitation. [2023] Transcatheter edge-to-edge mitral valve repair (TEER) has been established as a therapy for severe symptomatic mitral regurgitation (MR) in stable patients, and it has recently emerged as a reasonable option for acutely ill patients. The aim of this study was to evaluate the safety and efficacy of TEER in hospitalized patients with acute decompensated heart failure (ADHF) and severe MR that was deemed to play a major role in their deterioration.

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

Mitral valve surgery after failed MitraClip-Operation for the inoperable? [2023] Percutaneous edge-to-edge mitral valve repair technique (MitraClip) is a widely used treatment for mitral regurgitation (MR) in patients assessed with high surgical risk or inoperability. Only limited experiences with this highest-risk patient population exist. Procedural failure for MitraClip or recurrent MR is a strong predictor of 1-year mortality. Open mitral valve surgery constitutes the last bailout for patients within this cohort.