WiSE CRT System for Heart Failure

(SOLVE-CRT Trial)

Not currently recruiting at 83 trial locations

Overseen By Saumil Oza, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: EBR Systems, Inc.

Must be taking: Guideline directed medical therapy

Must not be taking: Chronic anticoagulants, antiplatelet agents

Disqualifiers: RBBB, Renal dysfunction, Atrial fibrillation, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and effectiveness of the WiSE System, a new treatment for individuals with heart failure who need Cardiac Re-synchronization Therapy (CRT). The treatment focuses on those who have not responded to previous CRT devices or who could not receive full treatment due to complications like challenging heart anatomy or other risks. Suitable candidates for this trial include individuals already on stable heart failure medication who have experienced difficulties with previous CRT treatments. As an unphased trial, this study offers a unique opportunity for patients to explore a novel treatment option that might address their specific challenges with CRT.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be on stable Guideline Directed Medical Therapy (GDMT), which suggests you may need to continue your current heart-related medications.

What prior data suggests that the WiSE System is safe for cardiac re-synchronization therapy?

Research has shown that the WiSE System, designed to improve heart function, is under study for safety. In one study, about 5.6% of patients experienced serious complications within six months, including three procedure-related deaths. However, 70% of patients reported feeling better after the treatment.

This indicates that while the system may alleviate heart failure symptoms, it carries some risks. Patients should consult their healthcare provider to understand the implications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for heart failure that often rely on implantable devices with leads, the WiSE CRT System is unique because it delivers wireless cardiac resynchronization therapy. This wireless approach eliminates the need for lead wires, reducing the risk of complications associated with lead placement and maintenance. Researchers are excited about this system because it can potentially offer a safer and more efficient alternative for patients who might not be candidates for traditional lead-based therapies.

What evidence suggests that the WiSE System is effective for heart failure?

Research has shown that the WiSE System, a new heart treatment using ultrasound, offers promising results for people with heart failure. In earlier studies, patients experienced significant improvements in heart failure symptoms and heart function. These positive changes included better heart pumping and reduced heart size, both crucial for managing heart failure. Approximately 40% of patients who qualify for traditional heart treatments do not respond well, but the WiSE System, which participants in this trial will receive, offers an alternative that might work better for some. This new method could enhance the quality of life and health outcomes for heart failure patients. ^{1 4 6 7 8}

Who Is on the Research Team?

Mary Walsh, M.D.

Principal Investigator

St. Vincent Heart Center

Jagmeet Singh, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with heart failure who haven't improved with standard treatments and are on stable medication. It's for those needing a CRT-D device implant, have failed previous attempts or can't have traditional leads due to risks. Patients must be able to follow the study plan and attend follow-ups.

Inclusion Criteria

My heart's pumping ability is reduced, and I have a specific heart rhythm pattern.

This criterion does not apply to me.

"High risk upgrade" status.

Exclusion Criteria

I cannot attend follow-up visits or comply with the trial's procedures due to physical or mental reasons.

I cannot take heparin or long-term blood thinners.

I haven't had a long AF episode or needed cardioversion in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the WiSE-CRT System therapy along with Guideline Directed Medical Therapy

6 months

Regular visits for monitoring and adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up visits at 6 months

What Are the Treatments Tested in This Trial?

Interventions

• WiSE System

Trial Overview The WiSE-CRT System is being tested in this study. This system aims to improve heart function by resynchronizing its beating pattern using wireless technology instead of traditional wired leads. The trial will compare safety and effectiveness against current methods.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

WiSE System therapy ON with Guideline Directed Medical Therapy

Who Is Running the Clinical Trial?

EBR Systems, Inc.

Lead Sponsor

Trials

6

Recruited

540+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2821182

Leadless Ultrasound-Based Cardiac Resynchronization ... Importance Approximately 40% of patients with heart failure (HF) who are eligible for cardiac resynchronization therapy (CRT) either fail to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11292567/

Leadless Ultrasound-Based Cardiac Resynchronization ... Approximately 40% of patients with heart failure (HF) who are eligible for cardiac resynchronization therapy (CRT) either fail to respond or are ...

3. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(21)01808-7/fulltext

Leadless left ventricular stimulation with WiSE-CRT System Favorable clinical responses in heart failure symptoms and significant LV reverse remodeling were noted. Keywords. Cardiac resynchronization ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1547527123022063

RESULTS FROM THE SOLVE-CRT STUDY LB-456088-4 SAFETY AND EFFICACY OF A LEADLESS ULTRASOUND-BASED CARDIAC RESYNCHRONIZATION PACING SYSTEM IN HEART FAILURE – RESULTS FROM THE SOLVE-CRT STUDY.

5. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.823797/full

WiSE CRT Is Beneficial for Heart Failure Patients as a ... Cardiac resynchronization therapy (CRT) has been proven to be an effective way to improve the prognosis and mortality of patients with cardiac ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7397503/

A multicenter international registry of the WiSE-CRT pacing ... Five deaths (5.6%) occurred within 6 months (3 procedure related). Seventy percent of patients had improvement in heart failure symptoms. Conclusion. BiV ENDO ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/P240028D.pdf

WiSE® Cardiac Resynchronization Therapy (CRT) System A patient with these implanted devices can be safely scanned in an MR system meeting the following conditions. Failure to follow these conditions may result in ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39083254/

Leadless Ultrasound-Based Cardiac Resynchronization ... Importance: Approximately 40% of patients with heart failure (HF) who are eligible for cardiac resynchronization therapy (CRT) either fail to ...