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Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients (SOLVE-CRT)

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ClinicalTrials.gov Identifier: NCT02922036
Recruitment Status : Recruiting
First Posted : October 3, 2016
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
EBR Systems, Inc.

Brief 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.

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 : 192 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders, Previously Untreatable and High Risk Upgrade Patients (SOLVE CRT)
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : December 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.




Primary Outcome Measures :
  1. Primary Safety [ Time Frame: 6 Months ]
    Freedom from Procedure and Device System related Type 1 Complications

  2. Primary Efficacy 1 [ Time Frame: 6 Months ]
    Mean relative % change in Left Ventricular End Systolic Volume (LVESV) baseline to 6 Months.


Secondary Outcome Measures :
  1. Secondary Efficacy 1 [ Time Frame: 6 Months ]
    Electrode Acoustic Pacing Capture Threshold (APCT) measured at the 6-month follow-up post-implant visit

  2. Secondary Efficacy 2 [ Time Frame: 6 Months ]
    Electrode Acoustic Pacing Capture Threshold Stability (APCT Stability) measured from pre-discharge through the 6-month follow-up post-implant visit

  3. Secondary Efficacy 3 [ Time Frame: 6 months ]
    % Bi-ventricular pacing (total number of WiSE paced beats / total number of co-implant RV-paced beats) at 6 months

  4. Secondary Efficacy 4 [ Time Frame: 6 months ]
    EF responder analysis for ≥ 5% absolute increase from baseline to 6 months.

  5. Secondary Efficacy 5 [ Time Frame: 6 months ]
    KCCQ responder analysis for ≥ 5 points absolute increase from 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/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' [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

    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. Patients with a prosthetic aortic valve in which the electrode cannot be implanted via a transseptal approach
  14. Patients with a prosthetic mitral valve in which the electrode cannot be implanted via a retrograde aortic approach
  15. Unstable angina, acute MI, CABG, or PTCA within the past 1 month
  16. Correctable valvular disease that is the primary cause of heart failure
  17. Recent CVA or TIA (within the previous 3 months)
  18. Patients with a history of paroxysmal or persistent atrial fibrillation/flutter are excluded if they have had a documented AF episode > 30 min or a cardioversion in the past 1 month.
  19. Patients with permanent AF are excluded if they have intact AV node conduction (RV pacing <95%)
  20. Already included in another clinical study that could confound the results of this study
  21. Pregnancy
  22. Known drug or alcohol addiction or abuse
  23. Moderate or severe aortic stenosis
  24. Positive test for COVID-19 at screening
  25. 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
  26. For Part II Randomized patients only, those who 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: Paulette Niemyski 6307405721 paulette.niemyski@ebrsystemsinc.com

Locations
Show Show 57 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: February 8, 2021
Last Verified: February 2021
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