Achieving Conduction System Activation With Leadless Left Ventricular Endocardial Pacing (ACCESS-CRT)
December 19, 2022 updated by: Guy's and St Thomas' NHS Foundation Trust
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Leadless Conduction System Pacing
Participants receive leadless conduction system pacing using the 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Procedure/Device related complication rate
Time Frame: 6 months
|
Number of procedure or device related complications
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Success rate
Time Frame: 6 months
|
Percentage of successful tracking
|
6 months
|
|
LV function
Time Frame: 6 months
|
Percentage of patients with a 15% reduction in LV end systolic volume
|
6 months
|
|
Clinical outcome
Time Frame: 6 months
|
Percentage of patients with improvement in NYHA class
|
6 months
|
|
ECG outcome
Time Frame: 6 months
|
Mean change in QRS duration
|
6 months
|
|
Biventricular activation time
Time Frame: 6 weeks
|
Mean change in biventricular activation time
|
6 weeks
|
|
Haemodynamic improvement
Time Frame: 6 weeks
|
Mean change in acute haemodynamic dP/dT
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.