Achieving Conduction System Activation With Leadless Left Ventricular Endocardial Pacing

Heart Failure Clinical Trial

— ACCESS-CRT  

Official title:

Achieving Conduction System Activation With Leadless Left Ventricular Endocardial Pacing

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05659680
• Other study ID #: 307507
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: January 2025

Study information

• Verified date: October 2022
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• WiSE-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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	King's College London

Outcome

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