MitraClip for Mitral Regurgitation
(SMARTER-CMR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates a treatment for individuals with heart failure who have secondary mitral regurgitation. The study examines how the MitraClip device, which improves mitral valve closure, impacts heart function and overall health outcomes. Participants will undergo heart scans and answer quality of life questions before and after the treatment. This trial may suit adults with heart failure and reduced heart pumping ability, who are already receiving medical treatment and experiencing significant mitral valve issues.
As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.
Do I have to stop taking my current medications for the trial?
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 doctor.
What is the safety track record for the MitraClip used in this study?
Research has shown that the MitraClip device, used in a procedure called TEER (transcatheter edge-to-edge repair), is safe. Studies have found that this procedure effectively reduces mitral regurgitation, a condition where blood leaks backward through a heart valve.
The MitraClip has been used for many years and is well-established, with proven safety and survival rates. This procedure is FDA-approved, indicating it has met safety standards for other conditions, which adds confidence in its use for treating mitral regurgitation.
While all medical procedures carry some risks, long-term data on the MitraClip suggest it is generally well-tolerated. Those considering joining a trial involving the MitraClip may find these findings reassuring regarding its safety.12345Why are researchers excited about this trial?
Researchers are excited about MitraClip for secondary mitral regurgitation because it offers a minimally invasive way to repair the mitral valve, which is different from traditional surgical options. Most treatments require open-heart surgery, but MitraClip is delivered via a catheter, reducing recovery time and potential complications. Additionally, the use of cardiac magnetic resonance (CMR) imaging in this trial helps to precisely assess heart function and treatment impact, potentially leading to more tailored and effective patient care.
What is the effectiveness track record for the MitraClip in TEER procedures?
Studies have shown that the MitraClip, used in transcatheter edge-to-edge repair (TEER), effectively treats mitral regurgitation, a condition where the heart's mitral valve doesn't close tightly. Research indicates that it significantly reduces symptoms, with over 90% of patients experiencing lasting improvement after one year. Long-term data from trials demonstrate that the MitraClip reduces hospital visits for heart failure and lowers death rates. Patients have also reported a better quality of life after using this device. The FDA has approved the MitraClip, and its benefits for treating mitral valve problems are well-documented. Participants in this trial will undergo guideline-directed TEER with the FDA-approved MitraClip.678910
Who Is on the Research Team?
João Cavalcante, MD
Principal Investigator
Minneapolis Heart Institute Foundation
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo a baseline CMR study with gadolinium and complete a quality-of-life questionnaire
Treatment
Participants undergo TEER procedure with MitraClip
6-Month Follow-up
Participants return for a follow-up CMR study, echocardiogram, and repeat quality-of-life questionnaire
Long-term Follow-up
Electronic Health Records reviewed and phone contact performed yearly for up to three years to evaluate clinical outcomes
What Are the Treatments Tested in This Trial?
Interventions
- MitraClip
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Cohort will undergo a clinically indicated baseline CMR study with contrast up to 90 days before TEER procedure. Quality of life questionnaire will also be completed. At 6 months, individuals will return to the clinic to repeat quality of life questionnaires, the CMR study and a transthoracic echocardiogram.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Minneapolis Heart Institute Foundation
Lead Sponsor
Citations
Mitral Valve Transcatheter Edge‐to‐Edge Repair or ...
The present study encompasses all available randomized data on M‐TEER at the longest follow‐up and shows likely reductions in all‐cause death, ...
1-Year Outcomes of Fourth-Generation Mitral ...
Conclusions: This first report of echocardiography core laboratory-assessed outcomes with the fourth-generation M-TEER system in Japan shows ...
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.
Transcatheter edge-to-edge repair for mitral regurgitation
Currently, the longest available follow-up after M-TEER includes the 5-year outcomes from the EVEREST II and COAPT trials, along with a 5-year analysis from a ...
Five-Year Follow-up after Transcatheter Repair ...
Transcatheter edge-to-edge repair of the mitral valve was safe and led to a lower rate of hospitalization for heart failure and lower all-cause mortality ...
6.
cardiovascular.abbott
cardiovascular.abbott/us/en/hcp/products/structural-heart/transcatheter-valve-solutions/mitraclip.htmlMitraClip Transcatheter Mitral Valve Repair
MitraClip is a well-established procedure with the highest-reported to date MR reduction, proven safety and survival, and durable clinical outcomes.
7.
structuralheart.abbott
structuralheart.abbott/products/transcatheter-mitral-valve-repair/mitraclip-tmvr-teerMitraClip Transcatheter Mitral Valve Repair (TMVr)
MitraClip is the world's first transcatheter mitral valve repair (TMVr) therapy that delivers a treatment option for patients with mitral regurgitation.
analysis of 10-years post-marketing death ... - PubMed Central
Death incidents following transcatheter edge-to-edge repair (TEER) with the MitraClip device: analysis of 10-years post-marketing death reports ...
Transcatheter Edge-to-Edge Repair (TEER)
TEER approximates the anterior and posterior mitral valve leaflets by grasping them with a clipping device in an approach similar to a treatment ...
MitraClip Transcatheter Mitral Valve Repair | Physician Site
*TMVr is now also referred to as TEER (transcatheter edge-to-edge repair) ... SEE MITRACLIP effectiveness AND SAFETY DATA · FIND A MITRACLIP CLINIC.
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