Percutaneous vs Surgical Repair for Mitral Valve Regurgitation (PRIMARY Trial)
Palo Alto (17 mi)Age: 65+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Annetine Gelijns
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.
What safety data is available for mitral valve repair treatments?The safety data for mitral valve repair treatments, particularly Transcatheter Edge-to-Edge Repair (TEER) using devices like MitraClip and PASCAL, includes insights from various studies. The OCEAN-Mitral Registry provides short-term outcomes for TEER, highlighting its safety and efficacy. The CLASP study reports favorable three-year outcomes for the PASCAL system. However, there is a noted need for surgical reintervention in some cases, as indicated by the Society of Thoracic Surgeons Database Analysis. Additionally, TEER has been evaluated for its safety and efficacy in patients with acute decompensated heart failure due to severe mitral regurgitation, showing it as a viable option for acutely ill patients.15678
Is Mitral valve repair, TEER a promising treatment for Mitral Valve Regurgitation?Yes, Mitral valve repair, TEER is a promising treatment for Mitral Valve Regurgitation. It is effective and less invasive, showing favorable outcomes in studies, especially for patients who are at high risk for surgery.14568
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are on an investigational drug or treatment that hasn't completed its primary endpoint, you may not be eligible to participate.
What data supports the idea that Percutaneous vs Surgical Repair for Mitral Valve Regurgitation is an effective treatment?The available research shows that Percutaneous Repair, also known as Transcatheter Edge-to-Edge Repair (TEER), is an effective treatment for Mitral Valve Regurgitation. The CLASP study reported positive outcomes over three years, indicating that this less invasive method can be beneficial. Additionally, the OCEAN-Mitral Registry highlights that TEER, including the latest MitraClip system, is safe and effective for a large group of patients. While there are some conflicting data about its long-term impact, TEER is particularly useful for patients who are not suitable for open-heart surgery, as it can relieve symptoms and improve outcomes.23568
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
I am 65 or older with severe valve leakage as shown by an echo test.
I am a candidate for a specific heart valve repair procedure as assessed by my heart care team.
I can walk for 6 minutes and fill out a heart disease questionnaire.
Exclusion Criteria
I have a thickened heart muscle that obstructs blood flow.
I need surgery on my heart valves or aorta.
My heart valve issue is not due to wear and tear.
I have an active infection in my heart's lining.
I do not have conditions that prevent me from using blood thinners.
I need a procedure to improve blood flow to my heart.
I need emergency surgery or intervention.
I have a mass or clot inside my heart.
I do not have severe heart issues like very low blood pressure or need for heart support devices.
Treatment Details
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.
2Treatment groups
Active Control
Group I: Surgical mitral valve repairActive Control1 Intervention
Patients who are randomized to the surgical arm will undergo mitral surgery.
Group II: Transcatheter edge-to-edge repairActive Control1 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 nearbySelect from list below to view details:
West Virginia University HospitalMorgantown, WV
Emory UniversityAtlanta, GA
Cleveland ClinicCleveland, OH
Baylor, Scott and WhiteDallas, TX
More Trial Locations
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Who is running the clinical trial?
Annetine GelijnsLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
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.
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.
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.).
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.
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.
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.
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.
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.