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Cardiac Resynchronization Therapy

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

N/A
Waitlist Available
Led By Mary N Walsh, MD, MACC
Research Sponsored by EBR Systems, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Class IIa (2): NYHA II, III, IV, EF≤ 35%, non-LBBB, QRS ≥ 150ms
OR
Must not have
Subject unable to attend follow-up at the investigative center or unable, for physical or mental reasons, or to comply with the trial's procedures
Contraindication to heparin, chronic anticoagulants or antiplatelet agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new heart device to see if it is safe and effective.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include complications from the implant procedure like infection, bleeding, or damage to heart structures; issues related to device performance such as improper sensing or pacing; and typical risks associated with cardiac procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My heart's pumping ability is reduced, and I have a specific heart rhythm pattern.
Select...
This criterion does not apply to me.
Select...
I am recommended to get a CRT-D device as per guidelines.
Select...
My attempt at getting a CRT device through CS lead implantation failed.
Select...
My heart is suitable for the WiSE CRT System implant.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot attend follow-up visits or comply with the trial's procedures due to physical or mental reasons.
Select...
I cannot take heparin or long-term blood thinners.
Select...
I haven't had a long AF episode or needed cardioversion in the last month.
Select...
I cannot stop my blood thinner medication for any procedures.
Select...
My heart failure is mainly due to a heart valve problem that can be fixed.
Select...
I have severe leakage in my heart's mitral valve.
Select...
My kidney function is very low.
Select...
I am on long-term dialysis.
Select...
I have a prosthetic mitral valve and cannot have an electrode placed through the artery.
Select...
I have been diagnosed with moderate or severe narrowing of my heart's aortic valve.
Select...
I have a prosthetic aortic valve and cannot have an electrode placed through the heart wall.
Select...
I cannot walk or have severe heart issues.
Select...
I am scheduled for a lithotripsy after getting an implant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Efficacy 1
Primary Safety
Secondary study objectives
Secondary Efficacy 1
Secondary Efficacy 2
Secondary Efficacy 3
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
WiSE System therapy ON with Guideline Directed Medical Therapy

Find a Location

Who is running the clinical trial?

EBR Systems, Inc.Lead Sponsor
5 Previous Clinical Trials
236 Total Patients Enrolled
4 Trials studying Heart Failure
136 Patients Enrolled for Heart Failure
Mary N Walsh, MD, MACCPrincipal InvestigatorSt. Vincent Heart Center
Jagmeet Singh, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
248 Total Patients Enrolled

Media Library

WiSE System (Cardiac Resynchronization Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02922036 — N/A
Heart Failure Research Study Groups: Treatment
Heart Failure Clinical Trial 2023: WiSE System Highlights & Side Effects. Trial Name: NCT02922036 — N/A
WiSE System (Cardiac Resynchronization Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02922036 — N/A
~20 spots leftby Jun 2025
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