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| Name | Class |
|---|---|
| King's College London | OTHER |
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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:
Participants will undergo pre-procedural cardiac CT, and post-procedure electro-anatomical mapping and haemodynamic assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leadless Conduction System Pacing | Experimental | Participants receive leadless conduction system pacing using the WiSE-CRT device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WiSE-CRT | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure/Device related complication rate | Number of procedure or device related complications | 6 months |
| 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 |
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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:
Exclusion Criteria:
Any contraindication to LV endocardial pacing.
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.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 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 |