Research Study: SOLVE-CRT
Condition: heart failure
Study Sponsor: EBR Systems
Study Investigator: Jay Sengupta, MD
Study Contact: Jessie Whelan
jessica.whelan@allina.com
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study: 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. 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.
Eligibility Criteria:

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)

Interested in participating in this study?

Reach out to the study contact directly, or fill out this form and we will contact you and assess whether you are an eligible candidate!