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Official title A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
ClinicalTrials.gov ID: NCT06561932
What this study is testing
- What it's testing
- Assess the safety and efficacy of the co-implantation of the WiSE CRT System with an intracardiac pacemaker to provide totally leadless CRT.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join 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...
- 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
You likely can't join 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
See the full eligibility 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...
- 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...
- 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...
- Group B: Upgrade chronic intracardiac pacemaker to CRT
- Patients with existing intracardiac pacemakers with greater than 20% RV pacing, who have developed symptomatic HF.
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Birtinya, Queensland, Australia
- Herston, Queensland, Australia
- Southport, Queensland, Australia
- Woolloongabba, Queensland, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birtinya, Queensland, Australia; Herston, Queensland, Australia; Southport, Queensland, Australia; Woolloongabba, Queensland, Australia. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.