Achieving Conduction System Activation With Leadless Left Ventricular Endocardial Pacing

NCT05659680 | Unknown

• 1 other identifier: 307507
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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. 1.What is the safety profile of leadless conduction system pacing?
2. 2.What is the success rate of leadless conduction system pacing?
3. 3.What are the electrical and haemodynamic effects of leadless conduction system pacing.

Conditions

Heart Failure

Keywords

heart failure; cardiac resynchronisation therapy; leadless pacing

Outcome Measures

Primary Outcomes (1)

• Procedure/Device related complication rate

  Number of procedure or device related complications

  6 months

Secondary Outcomes (6)

• Success rate

  6 months

• LV function

  6 months

• Clinical outcome

  6 months

• ECG outcome

  6 months

• Biventricular activation time

  6 weeks

Study Arms (1)

Leadless Conduction System Pacing

EXPERIMENTAL

Participants receive leadless conduction system pacing using the WiSE-CRT device.

Device: WiSE-CRT

Interventions

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.

Also known as: WiSE CRT

Leadless Conduction System Pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: December 21, 2022
• Study Start: January 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: January 1, 2025
• Last Updated: December 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share