Achieving Conduction System Activation With Leadless Left Ventricular Endocardial Pacing

Study Overview
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Brief Summary
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The goal of this prospective non-randomised study is to test the feasibility of leadless conduction system pacing using the WiSE-CRT device in patients with an indication for Cardiac Resynchronisation Therapy. The main question[s] it aims to answer are: What is the safety profile of leadless conduction system pacing? What is the success rate of leadless conduction system pacing? What are the electrical and haemodynamic effects of leadless conduction system pacing. Participants will undergo pre-procedural cardiac CT, and post-procedure electro-anatomical mapping and haemodynamic assessments.

Official Title
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Achieving Conduction System Activation With Leadless Left Ventricular Endocardial Pacing

Conditions
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Heart Failure

Intervention / Treatment
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* Device: WiSE-CRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years Ability to provide informed consent to participate and willing to comply with the clinical investigation plan and follow-up schedule. Patients meeting European Society of Cardiology Criteria for Cardiac Resynchronization Therapy (CRT) with Class 1 or 2a recommendation: Dyssynchronous Heart Failure: Left Ventricular Ejection Fraction (LVEF) ≤35%, QRS duration >150ms or >130ms in presence of left bundle branch block (LBBB). Also included here are patients with EF ≤35%, an existing pacing system and an RV pacing burden of >20%. BLOCK HF population: Patients requiring pacing for atrioventricular (AV) block with an LVEF ≤50% AV node ablation (AVNA) population: Patients planned for AVNA with EF ≤50%. Exclusion Criteria: Any contraindication to LV endocardial pacing. LV thrombus Contra-indication to heparin Contra-indication to anti-platelet agents Failure of acoustic window screening Septal wall thickness <5mm (minimum required wall thickness at any target implant site) Myocardial infarction within 40 days prior to enrolment. Cardiac surgery or coronary revascularisation procedure within 3 months prior to enrolment or to be scheduled for such procedures within the following 7 months. Participation in other studies with active treatment/investigational arm. Pregnant or planning to become pregnant in the next 7 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Leadless Conduction System Pacing<br>Participants receive leadless conduction system pacing using the WiSE-CRT device. | Device: WiSE-CRT<br>* Participants undergo pre-procedural CT, implantation of the WiSE-CRT system targeting the left bundle branch area, and post procedural non-invasive electro-anatomical mapping using electrocardiographic imaging and haemodynamic assessment.<br>* Other names: WiSE CRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure/Device related complication rate | Number of procedure or device related complications | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate | Percentage of successful tracking | 6 months | 
| LV function | Percentage of patients with a 15% reduction in LV end systolic volume | 6 months | 
| Clinical outcome | Percentage of patients with improvement in NYHA class | 6 months | 
| ECG outcome | Mean change in QRS duration | 6 months | 
| Biventricular activation time | Mean change in biventricular activation time | 6 weeks | 
| Haemodynamic improvement | Mean change in acute haemodynamic dP/dT | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, cardiac resynchronisation therapy, leadless pacing