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

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ClinicalTrials.gov Identifier: NCT02922036
Recruitment Status : Recruiting
First Posted : October 3, 2016
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
EBR Systems, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: WiSE System Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreatable Patients (SOLVE CRT)
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Experimental: Treatment
WiSE System therapy ON with Guideline Directed Medical Therapy
Device: WiSE System
The WiSE System is an implantable cardiac system to provide LV pacing stimulation in conjunction with a co-implanted system that provides right ventricular stimulation.

Sham Comparator: Control
WiSE System therapy OFF with Guideline Directed Medical Therapy
Device: WiSE System
The WiSE System is an implantable cardiac system to provide LV pacing stimulation in conjunction with a co-implanted system that provides right ventricular stimulation.




Primary Outcome Measures :
  1. Primary Safety [ Time Frame: 6 Months ]
    Freedom from Procedure and Device System related Type 1 Complications, Includes Electrode related complications such as dislodgement, migration, or malfunction; Vascular related complications that are procedure related (e.g. AV fistula, retroperitoneal bleed, pseudo aneurysm of the femoral artery, and bleeding requiring invasive correction or blood products); Transmitter/Battery pocket complications (e.g. infection, hematoma); and Stroke/TIA

  2. Primary Efficacy 1 [ Time Frame: 6 Months ]
    Mean change in Left Ventricular End Systolic Volume (LVESV) compared between arms (baseline to 6 Months). Measure in mili-liter difference between arms.

  3. Primary Efficacy 2 [ Time Frame: 6 Months ]
    LVESV Distribution Shift, defined as the percentage of subjects with an improvement of greater than 15% in LVESV, compared between arms (baseline to 6 Months)

  4. Primary Efficacy 3 [ Time Frame: 6 Months ]
    Proportion of subjects improved on a clinical composite compared between arms (baseline to 6 Months). Measure of New York Class Association (NYHA), Quality of Life (QOL), Heart Failure (HF) Events and death.


Secondary Outcome Measures :
  1. Secondary Efficacy 1 [ Time Frame: 6 Months ]
    Electrode Acoustic Pacing Capture Threshold (APCT) measured from predischarge through the 6-month follow-up post-implant visit (in the Treatment arm). The secondary efficacy APCT endpoint has a criteria of attainment of an APCT less than or equal to 2.9 milli-joules (mJ).

  2. Secondary Efficacy 2 [ Time Frame: 6 Months ]
    Electrode Acoustic Pacing Capture Threshold Stability (APCT Stability) measured from predischarge through the 6-month follow-up post-implant visit (in the Treatment arm). Demonstration of APCT stability through 6 months, is defined as a less than 3x relative change from predischarge in APCT.


Other Outcome Measures:
  1. Tertiary Efficacy 1 [ Time Frame: 6 Months ]
    The mean change in NT-proBNP from baseline, compared between arms (baseline to 6 months

  2. Tertiary Efficacy 2 [ Time Frame: 6 Months ]
    The proportion of subjects with a greater than 5% change in EF, compared between arms (baseline through 6 months)

  3. Tertiary Efficacy 3 [ Time Frame: 6 Months ]
    The mean change in intrinsic QRS duration, compared between arms (baseline to 6 months)

  4. Tertiary Efficacy 4 [ Time Frame: 6 Months ]
    The percent subjects with at least a one class improvement in NYHA, compared between arms (baseline to 6 months)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922036


Contacts
Contact: Mark Schwartz (408) 720-1906 ext 230 mark@ebrsystemsinc.com
Contact: Ashleigh Willson ashleigh@ebrsystemsinc.com

  Hide Study Locations
Locations
United States, Indiana
St. Vincent's Hospital and Healthcare Center Not yet recruiting
Indianapolis, Indiana, United States, 46290
Contact: Laurie Bogard    317-338-6450    laurie.bogard@ascension.org   
Principal Investigator: Eric Prystowsky, MD         
United States, Iowa
University of Iowa Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Michael Giudici, MD         
United States, Kentucky
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
Contact: Gery Tomassoni, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kevin Heist, MD, PhD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Marc Lahiri, MD         
Henry Ford Hospital Not yet recruiting
Detroit, Michigan, United States, 94062
Sparrow Hospital Recruiting
Lansing, Michigan, United States, 48912
Contact: John Ip, MD         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Hannah Frost       Frost.hannah@mayo.edu   
Principal Investigator: Yong-Mei Cha, MD         
United Heart and Vascular Clinic Not yet recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Nicole Gernes    651-241-2216    Nicole.Gernes@allina.com   
Principal Investigator: Alan Bank, MD         
United States, New York
Mount Sinai Hospital Not yet recruiting
New York, New York, United States, 10029
Contact: Marc Miller, MD         
Weill Cornell Medical Center Recruiting
New York, New York, United States, 10065
Contact: James Ip, MD         
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Niraj Varma, MD         
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Toshimasa Okabe, MD         
United States, Pennsylvania
UPMC Heart and Vascular Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Samir Saba, MD         
United States, South Carolina
MUSC Gazes Research Institute Recruiting
Charleston, South Carolina, United States, 29425
Contact: Debi Everidge, MD    843-876-4762    adamsde@musc.edu   
Principal Investigator: Lacy Studivant, MD         
United States, Texas
The Heart Hospital Baylor Plano Not yet recruiting
Plano, Texas, United States, 75093
Contact: Steven Kindsvater, MD         
Contact: Destiny Barnett         
United States, Wisconsin
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Imran Niazi, MD         
Australia, Queensland
Prince Charles Hospital Recruiting
Chermside, Queensland, Australia, 4032
Contact: Haris Haqqani, MD         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Prash Sanders, MD         
Australia, Victoria
Monash Heart Recruiting
Clayton, Victoria, Australia, 3168
Contact: Jeffrey Alison, MD         
University Hospital Geelong Recruiting
Geelong, Victoria, Australia, 3220
Contact: Mark Perrin, MD         
Austin Health Not yet recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Louise Brown       louise.brown@austin.org.au   
Principal Investigator: Dr. David O'Donnell         
Australia, Western Australia
Fiona Stanley Hospital Recruiting
Perth, Western Australia, Australia, 6150
Contact: Vince Paul, MD         
Australia
Royal Prince Alfred Hospital Recruiting
Camperdown, Australia, 2050
Contact: Dr. Raymond Sy         
Denmark
Aalborg University Hospital Not yet recruiting
Aalborg, Denmark
Contact: Pauline Johansen       pgb@rn.dk   
Principal Investigator: Sam Riahi         
Germany
Immanuel Klinikum Bernau - Herzzentrum Brandenburg Recruiting
Bernau, Germany, 16321
Contact: Christian Butter, MD         
Universitätsklinikum Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Martin Arnold, MD         
Universitäres Herzzentrum Hamburg (UKE Hamburg) GmbH (UHZ) Not yet recruiting
Hamburg, Germany
Contact: Mrs. Kathrin Heitmann         
Principal Investigator: Prof. Dr. med. Christian Meyer         
Universitätsklinikum Münster Not yet recruiting
Münster, Germany, 48149
Contact: Kerstin Müller         
Principal Investigator: Prof. Dr. med. Lars Eckardt, MD         
Italy
Policlinico S. Orsola - Malpighi Recruiting
Bologna, Italy, 40138
Contact: Mauro Biffi, MD         
Contact: Igor Diemberger, MD         
Ospedale San Gerardo Recruiting
Monza, Italy
Contact: Dr. Giovanni Rovaris         
Netherlands
Isala Hartcentrum Recruiting
Zwolle, Netherlands, 8025 AB
Contact: P.P.H.M. Delnoy, MD         
United Kingdom
Harefield Hospital Recruiting
Harefield, United Kingdom, UB9 6JH
Contact: Mark Mason, MD         
Barts Heart Centre Recruiting
London, United Kingdom, EC1A 7BE
Contact: Anthony Chow, MD         
St. Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: Aldo Rinaldi, MD         
Manchester Heart Centre Not yet recruiting
Manchester, United Kingdom, M13 9WL
Contact: Sarah Mackie    1612763336    sarah.mackie@mft.nhs.uk   
Principal Investigator: Amir Zaidi         
James Cook University Hospital Recruiting
Middlesbrough, United Kingdom, TS4 3BW
Contact: Simon James, MD         
John Radcliffe Hospital Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Tim Betts, MD         
Sponsors and Collaborators
EBR Systems, Inc.
Investigators
Principal Investigator: Jagmeet Singh, MD, PhD Massachusetts General Hospital

Responsible Party: EBR Systems, Inc.
ClinicalTrials.gov Identifier: NCT02922036     History of Changes
Other Study ID Numbers: CSP-03035
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases