Achieving Conduction System Activation With Leadless Left Ventricular Endocardial Pacing (ACCESS-CRT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: WiSE-CRT

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Leadless Conduction System Pacing; Participants receive leadless conduction system pacing using the WiSE-CRT device.	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.; Other Names: WiSE CRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure/Device related complication rate	Number of procedure or device related complications	6 months

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: King's College London

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: heart failure; cardiac resynchronisation therapy; leadless pacing
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 307507

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No