Achieving Conduction System Activation With Leadless Left Ventricular Endocardial Pacing

Not Applicable

Not yet recruiting

• Conditions: Heart Failure
• Interventions: Device: WiSE-CRT

• Registration Number: NCT05659680
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-12-19
• Last Update Submitted: 2022-12-19
• Study First Posted: 2022-12-21
• Last Update Posted: 2022-12-21
• Study Start: 2023-01
• Primary Completion: 2024-07
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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%.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Leadless Conduction System Pacing	WiSE-CRT	Participants receive leadless conduction system pacing using the WiSE-CRT device.

Primary Outcome Measures

Name	Time	Method
Procedure/Device related complication rate	6 months	Number of procedure or device related complications

Secondary Outcome Measures

Name	Time	Method
ECG outcome	6 months	Mean change in QRS duration
Success rate	6 months	Percentage of successful tracking
Clinical outcome	6 months	Percentage of patients with improvement in NYHA class
LV function	6 months	Percentage of patients with a 15% reduction in LV end systolic volume
Biventricular activation time	6 weeks	Mean change in biventricular activation time
Haemodynamic improvement	6 weeks	Mean change in acute haemodynamic dP/dT