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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:January 17, 2018
End Date:September 2020
Contact:Brandi Johnson
Email:brandi.johnson@ebrsystemsinc.com
Phone:(408) 720-1906

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

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

Inclusion Criteria:

- Patient with a class I or IIa (1) or (2) indication for implantation of a (Cardiac
Resychronization Defibrillator) CRT-D device according to current available guidelines
AND are either 'Non-Responders' to Cardiac Resychronization Therapy (CRT) OR
'Previously Untreatable' (described below):

- Non-Responder: 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 6M. Non-response is defined as remaining clinically unchanged or worsened:

1. Ejection Fraction (EF) has remained unchanged or worsened, and

2. 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.

- Previously Untreatable: Patients who have a full or partial CRT system, who meet
general inclusion criteria and are deemed as 'previously untreatable' for one of
the following reasons:

1. Patients in whom coronary sinus (CS) lead implantation for CRT has failed

2. CS lead implanted has been programmed off due any of the following:

3. High risk upgrades: relative contraindications to CS lead implant

Exclusion Criteria:

- Pure Right Bundle Branch Block (RBBB)

- Left Ventriculart Diastolic Diameter (LVEDD) ≥ 8cm

- Non-ambulatory or unstable NYHA class IV

- Contraindication to heparin, chronic anticoagulants or antiplatelet agents

- Triple anitcoagulant patients who cannot tolerate peri-procedural stopping of
anticoagulation therapy must be excluded

- Patients receiving lithotripsy treatment

- Attempted device implant (pacemaker, Implantable cardioverter defibrillator (ICD),
CRT, Left ventricular (LV) lead) or successful co-implant within 1 month

- Life expectancy of < 12 months

- Chronic hemodialysis

- Stage 4 or 5 renal dysfunction defined as Glomerular Filtration Rate (GFR) <30

- Grade 4 mitral valve regurgitation

- Noncardiac implanted electrical stimulation therapy devices

- Mechanical aortic valves or transcatheter aortic valve replacement (TAVR) valves

- Unstable angina, acute myocardial infarction (MI), coronary artery bypass graft
(CABG), or percutaneous transluminal coronary angioplasty (PTCA) within the past 1
month

- Correctable valvular disease that is the primary cause of heart failure

- Recent cerebrovascular accident (CVA) or transient ischemic attack (TIA) (within the
previous 3 months)

- Persistent or permanent atrial arrhythmias (or cardioversion for atrial fibrillation)
within the past month

- Already included in another clinical study that could confound the results of this
study

- Pregnancy

- Known drug or alcohol addiction or abuse

- Moderate or severe aortic stenosis
We found this trial at
23
sites
Rochester, Minnesota 55905
Principal Investigator: Yong-Mei Cha, MD
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Dr. Saumya Sharma, MD
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Houston, TX
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Dr. Michael Shehata
Phone: 424-315-4467
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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Charleston, South Carolina 29425
Principal Investigator: Lacy Studivant, MD
Phone: 843-876-4762
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Charleston, SC
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Chermside, Queensland 4032
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Chermside,
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Indianapolis, Indiana 46290
Principal Investigator: Eric Prystowsky, MD
Phone: 317-338-6450
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Indianapolis, IN
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Jacksonville, Florida 32204
Principal Investigator: Dr. Saumil Oza, MD
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Jacksonville, FL
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1215 E Michigan Ave
Lansing, Michigan 48912
(517) 364-1000
Sparrow Hospital Sparrow has grown to become the region's largest health system, and its diverse...
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Lexington, Kentucky 40503
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Los Angeles, California 90033
Principal Investigator: Rahul Doshi, MD
Phone: 323-442-7983
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Los Angeles, CA
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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New York, New York 10029
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New York, New York 10065
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Pittsburgh, Pennsylvania 15232
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Plano, Texas 75093
Phone: 469-800-6100
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Redwood City, California 94062
Principal Investigator: Dr. Hardwin Mead, MD
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Saint Paul, Minnesota 55102
Principal Investigator: Alan Bank, MD
Phone: 651-241-2216
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Springfield, Illinois 62701
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