Achieving Conduction System Activation With Leadless Left Ventricular Endocardial Pacing

Launched by GUY'S AND ST THOMAS' NHS FOUNDATION TRUST · Dec 19, 2022

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Gender

ALL

Eligibility criteria

• 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.