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

Primary Purpose

Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
WiSE-CRT
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, cardiac resynchronisation therapy, leadless pacing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Leadless Conduction System Pacing

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Procedure/Device related complication rate
    Number of procedure or device related complications

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 18, 2022
    Last Updated
    December 19, 2022
    Sponsor
    Guy's and St Thomas' NHS Foundation Trust
    Collaborators
    King's College London
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05659680
    Brief Title
    Achieving Conduction System Activation With Leadless Left Ventricular Endocardial Pacing
    Acronym
    ACCESS-CRT
    Official Title
    Achieving Conduction System Activation With Leadless Left Ventricular Endocardial Pacing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    January 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Guy's and St Thomas' NHS Foundation Trust
    Collaborators
    King's College London

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. 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: What is the safety profile of leadless conduction system pacing? What is the success rate of leadless conduction system pacing? 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure
    Keywords
    heart failure, cardiac resynchronisation therapy, leadless pacing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Leadless Conduction System Pacing
    Arm Type
    Experimental
    Arm Description
    Participants receive leadless conduction system pacing using the WiSE-CRT device.
    Intervention Type
    Device
    Intervention Name(s)
    WiSE-CRT
    Other Intervention Name(s)
    WiSE CRT
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Procedure/Device related complication rate
    Description
    Number of procedure or device related complications
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Success rate
    Description
    Percentage of successful tracking
    Time Frame
    6 months
    Title
    LV function
    Description
    Percentage of patients with a 15% reduction in LV end systolic volume
    Time Frame
    6 months
    Title
    Clinical outcome
    Description
    Percentage of patients with improvement in NYHA class
    Time Frame
    6 months
    Title
    ECG outcome
    Description
    Mean change in QRS duration
    Time Frame
    6 months
    Title
    Biventricular activation time
    Description
    Mean change in biventricular activation time
    Time Frame
    6 weeks
    Title
    Haemodynamic improvement
    Description
    Mean change in acute haemodynamic dP/dT
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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