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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06561932




Registration number
NCT06561932
Ethics application status
Date submitted
8/08/2024
Date registered
20/08/2024
Date last updated
20/08/2024

Titles & IDs
Public title
A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
Scientific title
A Feasibility Study Into the Implant of the WiSE® CRT System With an Intracardiac
Secondary ID [1] 0 0
CSP-10002
Universal Trial Number (UTN)
Trial acronym
TLC-AU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - WiSE CRT System

Experimental: Single-arm, prospective, multicenter, observational study. - .WiSE System therapy ON with Guideline Directed Medical Therapy


Treatment: Devices: 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 code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Device and procedure related complications.
Timepoint [1] 0 0
1 month and 6 months
Primary outcome [2] 0 0
Bi-Ventricular capture on 12 lead EKG
Timepoint [2] 0 0
1 month and 6 months
Secondary outcome [1] 0 0
Change in ejection fraction (EF) from Baseline
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Change in in left ventricular end systolic volume (LVESV)
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Change in NYHA class
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Change in Six-minute walk test
Timepoint [4] 0 0
6 months

Eligibility
Key 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.
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Patients of Sunshine Coast University Hospital - Birtinya
Recruitment hospital [2] 0 0
Patients of Cairns Base Hospital - Cairns
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
Patients of Gold Coast University Hospital - Southport
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
4006 - Herston
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
EBR Systems, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06561932
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Gould, Prof
Address 0 0
Princess Alexandra Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Madhuri Bhat
Address 0 0
Country 0 0
Phone 0 0
408-720-1906
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06561932