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

NCT06561932 | Recruiting

• 1 other identifier: CSP-10002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Incidence of Device and procedure related complications.

  Primary Safety

  1 month and 6 months

• Bi-Ventricular capture on 12 lead EKG

  Performance

  1 month and 6 months

Secondary Outcomes (4)

• Change in ejection fraction (EF) from Baseline

  6 months

• Change in in left ventricular end systolic volume (LVESV)

  6 months

• Change in NYHA class

  6 months

• Change in Six-minute walk test

  6 months

Study Arms (1)

Single-arm, prospective, multicenter, observational study.

EXPERIMENTAL

.WiSE System therapy ON with Guideline Directed Medical Therapy

Device: WiSE CRT System

Interventions

WiSE CRT System DEVICE

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

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Class IIa (1): NYHA II, III, IV, EF ≤ 35%, LBBB, QRS ≥ 130 to \< 150 ms
• Class IIa (2): NYHA II, III, IV, EF ≤ 35%, non-LBBB, QRS ≥ 150 ms
• Patient or legally authorized representative can provide written authorization and/or consent per institution requirements
• Male or Female, aged 22 years or above
• Meets criteria for one of the two patient groups
• 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.
• 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.
• Group B: Upgrade chronic intracardiac pacemaker to CRT
• Patients with existing intracardiac pacemakers with greater than 20% RV pacing, who have developed symptomatic HF.

You may not qualify if:

• Patient who is or is expected to be inaccessible for follow-up visits
• Female participant who is pregnant, lactating, or planning pregnancy during the course of the study
• Inability to comply with the study follow-up or other study requirements
• History of chronic alcohol/ drug abuse and currently using alcohol/ drugs
• Non-ambulatory (or unstable) NYHA class 4
• Life expectancy less than 12 months
• 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.
• 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)

Sponsors & Collaborators

• EBR Systems, Inc.: lead

Study Sites (4)

Patients of Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia

NOT YET RECRUITING

Royal Brisbane and Women's Hospital

Herston, Queensland, 4006, Australia

NOT YET RECRUITING

Patients of Gold Coast University Hospital

Southport, Queensland, 4215, Australia

NOT YET RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Paul Gould, Prof

  Princess Alexandra Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Phillips

CONTACT

805-403-3675; clinical@ebrsystemsinc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm, prospective, multicenter, observational study.

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 20, 2024
• Study Start: December 18, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

AU (4)