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

NCT ID: NCT06561932

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-04-01

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.

Detailed Description

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single-arm, prospective, multicenter, observational study.

.WiSE System therapy ON with Guideline Directed Medical Therapy

Group Type: EXPERIMENTAL

WiSE CRT System

Intervention Type: 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.

Interventions

WiSE CRT System

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EBR Systems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Gould, Prof

Role: PRINCIPAL_INVESTIGATOR

Princess Alexandra Hospital

Locations

Patients of Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Patients of Gold Coast University Hospital

Southport, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Countries

Australia

Central Contacts

Christine Phillips

Role: CONTACT

clinical@ebrsystemsinc.com

805-403-3675

Facility Contacts

Leanne Palethorp

Role: primary

Leanne.Palethorp@health.qld.gov.au

Cindy Hall

Role: primary

cindy.hall@health.qld.gov.au

Other Identifiers

CSP-10002

Identifier Type: -

Identifier Source: org_study_id