Heart FailureACCESS-CRTNCT05659680
Achieving Conduction System Activation With Leadless Left Ventricular Endocardial Pacing
A study testing WiSE-CRT in people with Heart Failure, run by Guy's and St Thomas' NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- WiSE-CRT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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)
Show all 10Show fewer
- 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.
About this study
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.
- Conditions
- Heart Failure
- Being tested
- WiSE-CRT
- Keywords
- heart failure, cardiac resynchronisation therapy, leadless pacing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WiSE-CRTDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Leadless Conduction System Pacing | Experimental | Participants receive leadless conduction system pacing using the WiSE-CRT device. Receives: Device: WiSE-CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure/Device related complication rate
Number of procedure or device related complications
Measured: 6 months
Secondary outcomes (6)
Success rate
Percentage of successful tracking
Measured: 6 months
LV function
Percentage of patients with a 15% reduction in LV end systolic volume
Measured: 6 months
Clinical outcome
Percentage of patients with improvement in NYHA class
Measured: 6 months
ECG outcome
Mean change in QRS duration
Measured: 6 months
Biventricular activation time
Mean change in biventricular activation time
Measured: 6 weeks
Haemodynamic improvement
Mean change in acute haemodynamic dP/dT
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study startJan 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659680
- Sponsor's protocol ID
- 307507
- Acronym
- ACCESS-CRT
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Conduction System Activation With Leadless Left Ventricular Endocardial Pacing
- ClinicalTrials.gov ID
- NCT05659680
- Acronym / sponsor ID
- ACCESS-CRT / 307507
- Conditions
- Heart Failure
- Keywords
- heart failure, cardiac resynchronisation therapy, leadless pacing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leadless Conduction System Pacing | Experimental | Device: WiSE-CRTParticipants receive leadless conduction system pacing using the WiSE-CRT device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (10 listed)
- Any contraindication to LV endocardial pacing.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WiSE-CRTAlso: WiSE CRTParticipants 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. | Device | Leadless Conduction System Pacing |
Primary outcome
Procedure/Device related complication rate
Time frame: 6 months
Number of procedure or device related complications
6 secondary outcomes
Success rate
Time frame: 6 months
LV function
Time frame: 6 months
Clinical outcome
Time frame: 6 months
ECG outcome
Time frame: 6 months
Biventricular activation time
Time frame: 6 weeks
Haemodynamic improvement
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing WiSE-CRT in people with Heart Failure, run by Guy's and St Thomas' NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure/Device related complication rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.