A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
- Conditions
- Heart Failure
- Registration Number
- NCT06561932
- Lead Sponsor
- EBR Systems, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria:<br><br> - Patient with a class I or IIa (1) or (2) indication for implantation of a CRT device<br> according to current available guidelines 1,2,4 (with additional QRS criteria on<br> Class IIa (1)):<br><br> - Class I: NYHA II, III, IV, EF = 35%, LBBB, QRS = 150 ms<br><br> - Class IIa (1): NYHA II, III, IV, EF = 35%, LBBB, QRS = 130 to < 150 ms<br><br> - Class IIa (2): NYHA II, III, IV, EF = 35%, non-LBBB, QRS = 150 ms<br><br> - Patient or legally authorized representative can provide written authorization<br> and/or consent per institution requirements<br><br> - Male or Female, aged 22 years or above<br><br> - Meets criteria for one of the two patient groups<br><br> - Group A: De novo totally leadless CRT implant in whom the physician believes a<br> totally leadless approach would be beneficial (e.g., wish to avoid lifelong<br> transvenous lead implant, anatomical constraints, history of device infection).<br><br> - Patients with symptomatic AF and an uncontrolled heart rate who are<br> candidates for AV node ablation (irrespective of QRS duration and LVEF),<br> and in whom the physician believes a leadless pacing approach would be<br> beneficial.<br><br> - Patients with high degree AV block who have an indication for permanent<br> pacing (with a LVEF = 50%), are expected to require ventricular pacing<br> more than 40% of the time, and in whom the physician believes a leadless<br> approach would be beneficial.<br><br> - Group B: Upgrade chronic intracardiac pacemaker to CRT<br><br> - Patients with existing intracardiac pacemakers with greater than 20% RV<br> pacing, who have developed symptomatic HF.<br><br>Exclusion Criteria:<br><br> - Patient who is or is expected to be inaccessible for follow-up visits<br><br> - Female participant who is pregnant, lactating, or planning pregnancy during the<br> course of the study<br><br> - Inability to comply with the study follow-up or other study requirements<br><br> - History of chronic alcohol/ drug abuse and currently using alcohol/ drugs<br><br> - Non-ambulatory (or unstable) NYHA class 4<br><br> - Life expectancy less than 12 months<br><br> - Any other significant disease or disorder which, in the opinion of the Investigator,<br> may either put the participants at risk because of participation in the study, or<br> may influence the result of the study, or the participant's ability to participate<br> in the study.<br><br> - Patient who is enrolled in another clinical study that could confound the results of<br> this study (Note: patients enrolled in complementary study are eligible for<br> enrolment)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Device and procedure related complications.;Bi-Ventricular capture on 12 lead EKG
- Secondary Outcome Measures
Name Time Method Change in ejection fraction (EF) from Baseline;Change in in left ventricular end systolic volume (LVESV);Change in NYHA class;Change in Six-minute walk test