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

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

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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.

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Eligibility criteria

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

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)

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Eligibility

Age eligible for study : 22 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2025-01-01

Primary completion: 2027-01-01

Study completion finish: 2027-01-01

Study type

TREATMENT

Phase

Trial ID

NCT06561932

Intervention or treatment

DEVICE: WiSE CRT System

Conditions

• Heart Failure

Condition: Heart Failure
DEVICE: WiSE CRT System
Herston, Queensland, Australia and more
Sponsor: EBR Systems, Inc.

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Find a site

Closest Location:

Royal Brisbane and Women's Hospital

Research sites nearby

Select from list below to view details:

Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Patients of Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Patients of Cairns Base Hospital
Cairns, Queensland, Australia

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/Arm	Intervention/Treatment
EXPERIMENTAL: Single-arm, prospective, multicenter, observational study. .WiSE System therapy ON with Guideline Directed Medical Therapy	DEVICE: 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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Change in ejection fraction (EF) from Baseline	Secondary efficacy 1	6 months
Change in in left ventricular end systolic volume (LVESV)	Secondary efficacy 2	6 months
Change in NYHA class	Secondary efficacy 3	6 months
Change in Six-minute walk test	Secondary efficacy 4	6 months

Frequently Asked Questions

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References

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