Heart Failure
Conditions
Keywords
heart failure, cardiac resynchronisation therapy, leadless pacing
Brief summary
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: 1. What is the safety profile of leadless conduction system pacing? 2. What is the success rate of leadless conduction system pacing? 3. 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.
Interventions
DEVICEWiSE-CRT
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.
Sponsors
King's College London
Guy's and St Thomas' NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure/Device related complication rate | 6 months | Number of procedure or device related complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LV function | 6 months | Percentage of patients with a 15% reduction in LV end systolic volume |
| Clinical outcome | 6 months | Percentage of patients with improvement in NYHA class |
| Success rate | 6 months | Percentage of successful tracking |
| Biventricular activation time | 6 weeks | Mean change in biventricular activation time |
| Haemodynamic improvement | 6 weeks | Mean change in acute haemodynamic dP/dT |
| ECG outcome | 6 months | Mean change in QRS duration |
Outcome results
None listed