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Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients

Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders, Previously Untreatable and High Risk Upgrade Patients (SOLVE CRT)

NCT02922036•EBR Systems, Inc.

View on ClinicalTrials.gov

Summary

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.

Detailed Description

The WiSE-CRT System is an implantable cardiac pacing system capable of delivering pacing energy to the left ventricle of the heart without using a pacing lead.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Inclusion/Exclusion:
•1. Patient with a class I or IIa (1) or (2) indication for implantation of a CRT-D device according to current available guidelines (with additional QRS criteria on Class IIa (1)):
•1. Class I: NYHA II, III, IV, EF ≤ 35%, LBBB, QRS ≥ 150ms
•2. Class IIa (1): NYHA II, III, IV, EF≤ 35%, LBBB, QRS ≥ 130 to \< 150ms
•3. Class IIa (2): NYHA II, III, IV, EF≤ 35%, non-LBBB, QRS ≥ 150ms
•2. Patient is a:
•1. 'Non-responder' \[Not Enrolling\]: Patients who have a CRT system that is functional and despite an adequate trial of Guideline Directed Medical Therapy (GDMT) and attempts at optimal device programming the patient has not responded to therapy for a minimum of 6 months. Non-response is defined as:
•* EF has remained unchanged or worsened (defined as \< 5% increase since implant), and
•* The patient's clinical status based in the totality of available clinical evidence (such as NYHA Class, exercise tolerance, QOL, or global assessment) has remained unchanged or worsened, as determined by the local Site Enrollment Committee
•OR
+14 more criteria

Exclusion Criteria

•Patients who meet any one of these criteria will be excluded from the investigation:
•1. Pure RBBB
•2. LVEDD ≥ 8cm
•3. Non-ambulatory or unstable NYHA class IV
•4. Contraindication to heparin, chronic anticoagulants or antiplatelet agents
•5. Triple anticoagulant patients who cannot tolerate peri-procedural stopping of anticoagulation therapy
•6. Attempted device implant (pacemaker, ICD, CRT, LV lead) or successful co-implant within prior 30 days.
•7. Patients with planned or expected lithotripsy treatment post implant
•8. Life expectancy of \< 12 months
•9. Chronic hemodialysis
+16 more criteria

Locations (68)

Heart Center Research

Huntsville, Alabama, United States

University of California, San Diego

La Jolla, California, United States

Broward Health Medical Center

Fort Lauderdale, Florida, United States

St. Vincent's Healthcare

Jacksonville, Florida, United States

Watson Clinic

Lakeland, Florida, United States

Naples Community Hospital

Naples, Florida, United States

Northside Hospital and Heart Institute

St. Petersburg, Florida, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Emory Healthcare

Atlanta, Georgia, United States

Prairie Heart

Springfield, Illinois, United States

Key Dates

Start Date

January 17, 2018

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2026

Last Updated

July 9, 2025

Enrollment

300

ESTIMATED participants

Conditions

Heart Failure

Interventions

WiSE System

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients

Inclusion Criteria

Exclusion Criteria

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