Heart Failure Clinical Trial
— ACCESS-CRTOfficial title:
Achieving Conduction System Activation With Leadless Left Ventricular Endocardial Pacing
Verified date | October 2022 |
Source | Guy's and St Thomas' NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 15 |
Est. completion date | January 2025 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Guy's and St Thomas' NHS Foundation Trust | King's College London |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedure/Device related complication rate | Number of procedure or device related complications | 6 months | |
Secondary | Success rate | Percentage of successful tracking | 6 months | |
Secondary | LV function | Percentage of patients with a 15% reduction in LV end systolic volume | 6 months | |
Secondary | Clinical outcome | Percentage of patients with improvement in NYHA class | 6 months | |
Secondary | ECG outcome | Mean change in QRS duration | 6 months | |
Secondary | Biventricular activation time | Mean change in biventricular activation time | 6 weeks | |
Secondary | Haemodynamic improvement | Mean change in acute haemodynamic dP/dT | 6 weeks |
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