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

Sponsor
Guy's and St Thomas' NHS Foundation Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05659680
Collaborator
King's College London (Other)
15
Enrollment
1
Arm
24
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: WiSE-CRT
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Achieving Conduction System Activation With Leadless Left Ventricular Endocardial Pacing
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Procedure/Device related complication rate [6 months]

      Number of procedure or device related complications

    Secondary Outcome Measures

    1. Success rate [6 months]

      Percentage of successful tracking

    2. LV function [6 months]

      Percentage of patients with a 15% reduction in LV end systolic volume

    3. Clinical outcome [6 months]

      Percentage of patients with improvement in NYHA class

    4. ECG outcome [6 months]

      Mean change in QRS duration

    5. Biventricular activation time [6 weeks]

      Mean change in biventricular activation time

    6. Haemodynamic improvement [6 weeks]

      Mean change in acute haemodynamic dP/dT

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guy's and St Thomas' NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT05659680
    Other Study ID Numbers:
    • 307507
    First Posted:
    Dec 21, 2022
    Last Update Posted:
    Dec 21, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Guy's and St Thomas' NHS Foundation Trust
    heart failure
    cardiac resynchronisation therapy
    leadless pacing
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Dec 21, 2022