WiSE CRT System for Heart Failure (SOLVE-CRT Trial)

Recruiting in Palo Alto (17 mi)

+82 other locations

Overseen ByMary Walsh, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: EBR Systems, Inc.

No Placebo Group

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.

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.

I am recommended to get a CRT-D device as per guidelines.

My attempt at getting a CRT device through CS lead implantation failed.

My heart is suitable for the WiSE CRT System implant.

I am 18 years old or older.

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.

I cannot stop my blood thinner medication for any procedures.

My heart failure is mainly due to a heart valve problem that can be fixed.

I have severe leakage in my heart's mitral valve.

My kidney function is very low.

I am on long-term dialysis.

I have a prosthetic mitral valve and cannot have an electrode placed through the artery.

I have been diagnosed with moderate or severe narrowing of my heart's aortic valve.

I have a prosthetic aortic valve and cannot have an electrode placed through the heart wall.

I cannot walk or have severe heart issues.

I am scheduled for a lithotripsy after getting an implant.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

WiSE System therapy ON with Guideline Directed Medical Therapy