Clinical trial NCT06561932: A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
Official title: A Feasibility Study Into the Implant of the WiSE® CRT System With an Intracardiac
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: EBR Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-20
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm, prospective, multicenter, observational study.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Incidence of Device and procedure related complications.
timeFrame: 1 month and 6 months
measure: Bi-Ventricular capture on 12 lead EKG
timeFrame: 1 month and 6 months
Secondary outcomes:
measure: Change in ejection fraction (EF) from Baseline
timeFrame: 6 months
measure: Change in in left ventricular end systolic volume (LVESV)
timeFrame: 6 months
measure: Change in NYHA class
timeFrame: 6 months
measure: Change in Six-minute walk test
timeFrame: 6 months
Other outcomes:
Locations:
city: Birtinya
country: Australia
facility: Patients of Sunshine Coast University Hospital
state: Queensland
city: Cairns
country: Australia
facility: Patients of Cairns Base Hospital
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Southport
country: Australia
facility: Patients of Gold Coast University Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
Study officials:
affiliation: Princess Alexandra Hospital
name: Paul Gould, Prof
role: PRINCIPAL_INVESTIGATOR
References: