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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)



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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

  Show 38 Study Locations
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