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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922036
Recruitment Status : Recruiting
First Posted : October 3, 2016
Last Update Posted : May 6, 2020
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-CRT System for Cardiac Re-synchronization Therapy.

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

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.

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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 : June 2021
Estimated Study Completion Date : December 2025

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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/Exclusion:

Inclusion Criteria

  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': 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

    2. '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:

    i. Patients in whom CS lead implantation for CRT has failed

    • CS lead implant was attempted but abandoned due any of the following: difficult CS access or anatomy, inadequate lead location, inadequate pacing thresholds, persistent phrenic nerve pacing, or other procedural challenges

    ii. CS lead implanted but has been programmed OFF

    • LV lead that was implanted but not operational includes patients in whom the LV lead is inoperative or programmed off due to improper function such as high threshold, non-capture, phrenic nerve pacing, lead failure, lead dislodgement, or sub-optimal LV lead location

    OR

    c. 'High Risk Upgrade:

    Patients who have a relative contraindication to CS lead implant, due to:

    • venous occlusion or lesion precluding implant
    • pocket infection risk (at co-implanted device site)
    • considered high risk for CS implant due to co-morbidities
  3. Patients on a stable Guideline Directed Medical Therapy (GDMT)
  4. Patient must be 18 years old or over
  5. Patient has signed and dated informed consent
  6. Patient has suitable anatomy for implant of the WiSE CRT System (e.g. adequate acoustic window, LV wall thickness in target implant area ≥ 5 mm, absence of LV wall structural abnormalities which may preclude implant)

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
  10. Stage 4 or 5 renal dysfunction defined as eGFR < 30
  11. Grade 4 mitral valve regurgitation
  12. Noncardiac implanted electrical stimulation therapy devices
  13. Mechanical aortic valves or TAVR valves
  14. Unstable angina, acute MI, CABG, or PTCA within the past 1 month
  15. Correctable valvular disease that is the primary cause of heart failure
  16. Recent CVA or TIA (within the previous 3 months)
  17. Atrial fibrillation/flutter: Patients with a history of paroxysmal or persistent atrial fibrillation/flutter may be included if they have been in sinus rhythm for the past 30 days, and have not had cardioversion in the past 30 days. Patients with AV node ablation may be included if they have not had symptomatic atrial fibrillation/flutter in the last 30 days, and have not had cardioversion in the past 30 days.
  18. Already included in another clinical study that could confound the results of this study
  19. Pregnancy
  20. Known drug or alcohol addiction or abuse
  21. Moderate or severe aortic stenosis
  22. Subject unable to attend follow-up at the investigative center or unable, for physical or mental reasons, or to comply with the trial's procedures
  23. Patient will not tolerate being randomized to the Control Group for 6 months

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
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Contact: Ashleigh Willson (408) 720-1906 ashleigh@ebrsystemsinc.com

Locations
Show Show 66 study locations
Sponsors and Collaborators
EBR Systems, Inc.
Investigators
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Principal Investigator: Jagmeet Singh, MD, PhD Massachusetts General Hospital
Principal Investigator: Mary N Walsh, MD, MACC St. Vincent Heart Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: EBR Systems, Inc.
ClinicalTrials.gov Identifier: NCT02922036    
Other Study ID Numbers: CSP-03035
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases