WiSE CRT System for Heart Failure

(SOLVE-CRT Trial)

Recruiting at 82 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

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a prospective, multi-center, pivotal trial to study the safety and efficacy of the WiSE-CRT System for Cardiac Re-synchronization Therapy.

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 data supports the effectiveness of the WiSE CRT System treatment for heart failure?

The WiSE CRT System is shown to be effective for patients who do not respond to conventional cardiac resynchronization therapy (CRT) or cannot have traditional CRT due to complications. It provides wireless pacing inside the heart, which can improve heart function and symptoms in these patients. ^{1 2 3 4 5}

Is the WiSE CRT System safe for humans?

The WiSE CRT System has been shown to be safe in studies for patients who couldn't use traditional heart devices. It offers a wireless way to help the heart beat better, and early research suggests it is safe and works well. ^{1 2 3 4 6}

How is the WiSE CRT System treatment different from other heart failure treatments?

The WiSE CRT System is unique because it provides wireless pacing directly inside the heart's left ventricle, unlike traditional methods that use wires on the heart's surface. This approach can help patients who don't respond to or can't receive conventional treatments, offering a more natural and effective way to synchronize the heart's pumping action. ^{1 2 3 4 6}

Research Team

Mary Walsh, M.D.

Principal Investigator

St. Vincent Heart Center

Jagmeet Singh, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Leadless endocardial ultrasound based left ventricular stimulation : WISE CRT System: alternative to conventional methods]. [2019]

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

Cardiac Resynchronization Therapy With Wireless Left Ventricular Endocardial Pacing: The SELECT-LV Study. [2018]

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

Leadless left ventricular endocardial pacing in nonresponders to conventional cardiac resynchronization therapy. [2021]

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

Modified design of stimulation of the left ventricular endocardium for cardiac resynchronization therapy in nonresponders, previously untreatable and high-risk upgrade patients (SOLVE-CRT) trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Judgement of the multidisciplinary team is an important predictor of mortality after cardiac resynchronization therapy. [2022]

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

Cost-effectiveness analysis of leadless cardiac resynchronization therapy. [2023]