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A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT

NARECRUITING

Assess the safety and efficacy of the co-implantation of the WiSE CRT System with an intracardiac pacemaker to provide totally leadless CRT.

Study details:

The WiSE CRT System is an implantable cardiac system to provide left ventricular (LV) pacing stimulation in conjunction with a co-implanted system that provides right ventricular (RV) stimulation. In combination, the devices deliver biventricular (BiV) pacing. Single-arm, prospective, multicenter, observational study.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Patient with a class I or IIa (1) or (2) indication for implantation of a CRT device according to current available guidelines 1,2,4 (with additional QRS criteria on Class IIa (1)): Class I: NYHA II, III, IV, EF ≤ 35%, LBBB, QRS ≥ 150 ms
  2. Class IIa (1): NYHA II, III, IV, EF ≤ 35%, LBBB, QRS ≥ 130 to < 150 ms
  3. Class IIa (2): NYHA II, III, IV, EF ≤ 35%, non-LBBB, QRS ≥ 150 ms
  4. Patient or legally authorized representative can provide written authorization and/or consent per institution requirements
  5. Male or Female, aged 22 years or above
  6. Meets criteria for one of the two patient groups
  7. Group A: De novo totally leadless CRT implant in whom the physician believes a totally leadless approach would be beneficial (e.g., wish to avoid lifelong transvenous lead implant, anatomical constraints, history of device infection): Patients with symptomatic AF and an uncontrolled heart rate who are candidates for AV node ablation (irrespective of QRS duration and LVEF), and in whom the physician believes a leadless pacing approach would be beneficial.
  8. Patients with high degree AV block who have an indication for permanent pacing (with a LVEF ≤ 50%), are expected to require ventricular pacing more than 40% of the time, and in whom the physician believes a leadless approach would be beneficial.
  9. Group B: Upgrade chronic intracardiac pacemaker to CRT: Patients with existing intracardiac pacemakers with greater than 20% RV pacing, who have developed symptomatic HF.

Exclusion criteria

  1. Patient who is or is expected to be inaccessible for follow-up visits
  2. Female participant who is pregnant, lactating, or planning pregnancy during the course of the study
  3. Inability to comply with the study follow-up or other study requirements
  4. History of chronic alcohol/ drug abuse and currently using alcohol/ drugs
  5. Non-ambulatory (or unstable) NYHA class 4
  6. Life expectancy less than 12 months
  7. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
  8. Patient who is enrolled in another clinical study that could confound the results of this study (Note: patients enrolled in complementary study are eligible for enrolment)

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    NA

trial

Study ID

NCT06561932

Intervention or treatment

DEVICE: WiSE CRT System

Conditions

  • Heart Failure

  • Condition: Heart Failure

  • DEVICE: WiSE CRT System

  • Birtinya, Queensland, Australia and more

  • Sponsor: EBR Systems, Inc.

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Patients of Sunshine Coast University Hospital

Select from list below to view details:

  • Patients of Sunshine Coast University Hospital

    Birtinya, Queensland, Australia

  • Patients of Cairns Base Hospital

    Cairns, Queensland, Australia

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, Australia

  • Patients of Gold Coast University Hospital

    Southport, Queensland, Australia

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Who is running the clinical trial?

ESI

EBR Systems, Inc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Single-arm, prospective, multicenter, observational study.
  • .WiSE System therapy ON with Guideline Directed Medical Therapy
Device: WiSE CRT System

    What is the study measuring?

    Primary Outcome

    MeasureDescriptionTime Frame
    Incidence of Device and procedure related complications.Primary Safety1 month and 6 months
    Bi-Ventricular capture on 12 lead EKGPerformance1 month and 6 months

    Secondary Outcome

    MeasureDescriptionTime Frame
    Change in ejection fraction (EF) from BaselineSecondary efficacy 16 months
    Change in in left ventricular end systolic volume (LVESV)Secondary efficacy 26 months
    Change in NYHA classSecondary efficacy 36 months
    Change in Six-minute walk testSecondary efficacy 46 months
    Are you running this trial?If you're a clinic or sponsor, you can claim this study.
    Claim this trial

    References

    Clinical Trials Gov: A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT

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