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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
SOLVE-CRT Trial 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.Check my eligibility
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.See study design
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.
SOLVE-CRT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
SOLVE-CRT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Efficacy 1
Primary Safety
Secondary outcome measures
Secondary Efficacy 1
Secondary Efficacy 2
Secondary Efficacy 3
+2 moreSOLVE-CRT 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
4 Previous Clinical Trials
196 Total Patients Enrolled
3 Trials studying Heart Failure
96 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot attend follow-up visits or comply with the trial's procedures due to physical or mental reasons.My heart's pumping ability is reduced, and I have a specific heart rhythm pattern.This criterion does not apply to me.I cannot take heparin or long-term blood thinners.I haven't had a long AF episode or needed cardioversion in the last month."High risk upgrade" status.I cannot stop my blood thinner medication for any procedures.I have had a heart device implant or attempted one in the last 30 days.I haven't had recent severe heart issues or procedures in the last month.My heart failure is mainly due to a heart valve problem that can be fixed.I have permanent atrial fibrillation but my heart's electrical signals are mostly not paced.I am recommended to get a CRT-D device as per guidelines.My previous attempts at CRT with CS lead were unsuccessful or not recommended due to high risks.I have severe leakage in my heart's mitral valve.You have a specific heart condition called pure right bundle branch block.My kidney function is very low.You have a noncardiac implanted electrical stimulation device.I am on long-term dialysis.I am not willing to be in the control group for 6 months.I have a prosthetic mitral valve and cannot have an electrode placed through the artery.You are expected to live for less than 12 months.It seems like the criterion is incomplete. Could you please provide more details or the full criterion for me to rewrite it in a simpler language?I am on a stable heart medication regimen as per guidelines.I have been diagnosed with moderate or severe narrowing of my heart's aortic valve.Your left ventricle is enlarged, measuring more than 8 centimeters.You have a known problem with drugs or alcohol.My attempt at getting a CRT device through CS lead implantation failed.I have not had a stroke or mini-stroke in the last 3 months.My heart is suitable for the WiSE CRT System implant.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.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any domestic venues where this clinical trial is being conducted?
"The current clinical trial is running in 42 different sites, including those located in Indianapolis, Sugar Land and New Brunswick. To reduce the need for travel during enrollment, patients should choose a clinic close to them."
Answered by AI
Are there any opportunities currently open for volunteers to participate in this trial?
"As per the hosted clinicaltrials.gov data, this study is still seeking participants and has been since its initial posting in January of 2018. It was last updated on November 2nd 2022."
Answered by AI
What is the ultimate objective of this research endeavor?
"This clinical trial, lasting for half a year, is designed to primarily assess safety. The secondary aims include evaluating KCCQ responder analysis with at least 5 points of absolute increase from baseline to 6 months, electrode acoustic pacing capture threshold stability measured pre-discharge and post-implant visit at the six month follow up as well as EF responder analysis requiring an absolute 5% increase in efficacy over that same period."
Answered by AI
How many participants is the research team accepting for this experiment?
"The study, led by EBR Systems Inc., necessitates 192 qualified participants and is based in multiple centres such as St. Vincent's Hospital and Healthcare Center located in Indianapolis, Indiana and Houston Methodist situated in Sugar Land, Texas."
Answered by AI
Who else is applying?
What state do they live in?
Iowa
What site did they apply to?
University of Iowa
What portion of applicants met pre-screening criteria?
Did not meet criteria
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