Heart FailureTLCNCT05451797
Implant of the WiSE CRT System With an Intracardiac Pacemaker
An observational study of Heart Failure, run by University Hospital Southampton NHS Foundation Trust.
Trial summary
This study is a single arm, prospective, feasibility, multi-centre, observational study. Participants will be suitable for a Cardiac Resynchronisation Therapy (CRT) implant using Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy, known as the WiSE-CRT device system as well as requiring a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Implant of WiSE-CRT with intracardiac pacemaker
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Dec 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients appropriate for these devices
Who may be able to join
- Male or Female, aged 18 years or above. Participant is willing and able to give informed consent for participation in the study.
- Additionally, participants will be enrolled and classified from one of two distinct groups:
- GROUP A: De novo totally leadless CRT
- implant in whom the physician believes a totally leadless approach would be beneficial (e.g. wish to avoid lifelong transvenous lead implant, anatomical constraints, history of device infection). Examples of this could include:
- symptomatic atrial fibrillation (AF) and an uncontrolled heart rate who are candidates for AV node ablation (irrespective of QRS duration and ejection fraction), in whom the physician believes a leadless pacing approach would be beneficial.
- high degree atrioventricular block who has an indication for permanent pacing, with an ejection fraction ≤50%, are expected to require ventricular pacing more than 40% of the time and in whom the physician believes a leadless approach would be beneficial.
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- Other indications for leadless pacing including venous obstruction, pocket issues, infection risk (eg: chronic dialysis), etc.
- GROUP B: Upgrade chronic intracardiac pacemaker to CRT
- o Patient with existing intracardiac pacemaker with greater than 20% right ventricular (RV) pacing, who have developed symptomatic heart failure.
Who cannot join
- Female participant who is pregnant, lactating or planning pregnancy during the course of the study
- Inability to comply with the study follow-up or other study requirements
- History of chronic alcohol/drug abuse and currently using alcohol/drugs
- Non-ambulatory (or unstable) NYHA class 4
- Life expectancy less than 12 months
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Enrolled in another clinical study that could confound the results of this study (note: patients enrolled in complementary study are eligible for enrolment)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Feasibility Study Into the Implant of the WiSE CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
This study is a single arm, prospective, feasibility, multi-centre, observational study. Participants will be suitable for a Cardiac Resynchronisation Therapy (CRT) implant using Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy, known as the WiSE-CRT device system as well as requiring a pacemaker implant which will also be leadless. Some of these participants may also require an AV Node ablation.
The purpose of this study is to assess the safety and efficacy of these two cardiac devices implanted in the order of operator preference (all implants undertaken on the same day or in a number of up to 4 separate sequenced implants/procedures).
Read the detailed description
Heart Failure is a serious condition in which the heart is unable to pump enough blood to meet the body's demands. Some heart failure occurs when the heart chambers pump in a desynchronised manner, reducing the amount of blood pumped with each heartbeat.
The National Institute for Health and Care Excellence (NICE) recommends Cardiac Resynchronisation Therapy (CRT) for a subset of these patients. Patients undergoing CRT receive a special implantable pacemaker with an additional lead via the coronary sinus (CS) to synchronise the pumping of the heart chambers (ventricles). CRT works by pacing both the left \& right ventricles to ensure they pump at the same time. This in turn, reduces heart failure symptoms.
CRT is an effective treatment for many patients, but limitations prevent some patients from benefiting:
- 5-10% of patients are considered untreated due to acute/chronic issues with the CS lead
- 30% of patients do not respond/improve
The WiSE-CRT System is an implantable pacing system capable of delivering pacing energy to the heart without using a pacing lead. It was designed to address the persistent limitations of current CRT systems. The WiSE-CRT System operates alongside a co-implanted pacemaker or CRT system and replaces the pacing function of the CS lead.
Intracardiac pacemakers are miniaturized, self-contained, pacing systems implanted directly inside the right ventricle of the heart, eliminating the need for a device pocket and pacing lead inserted into a vein.
By co-implanting both the European conformity certificated (CE marked) WiSE-CRT system and a leadless intracardiac pacemaker, this pilot study will assess the safety and efficacy of implanting a totally leadless system, thereby avoiding both acute and chronic complications associated with the implant of transvenous pacing leads.
This study is a single arm, prospective, multi-centre, observational study. Participants will have initial pre-implant screening baseline measurements prior to implantation of the first system, then will be followed up immediately post implant, then at 1 month \& 6 months post implant.
- Conditions
- Heart Failure
- Being tested
- Implant of WiSE-CRT with intracardiac pacemaker
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant of WiSE-CRT with intracardiac pacemakerDevice
Implant of two cardiac devices
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety from major complications post device implants & procedures
Freedom from major complications following device implants and procedures, whether single stage or multiple staged procedures. Major complications are defined as any complication related to the device or procedure that results in death, hospitalization, prolongation of hospitalisation for 48 or more hours, permanent loss of device function due to a mechanical or electrical malfunction or system change (removal, repositioning, or replacement).
Measured: 6 months
Efficacy of Cardiac Resynchronisation Therapy (CRT) measured by confirmation of Bi Ventricular Pacing on 12 lead ECG.
Evidence of biventricular pacing on 12 lead ECG recorded at 6 months will confirm CRT delivered by implanted devices for each participant.
Measured: 6 months
Secondary outcomes (4)
Clinical Response of Each Participant measuring Left Ventricular Ejection Fraction.
This will be measured by using a recognised clinical tool that reflects the participant's heart failure status by measuring the left ventricular contractility of the heart. Changes at 6 months (relative to baseline measurement) in Left Ventricular Ejection Fraction as a % from Transthoracic Echocardiogram (TTE) will be measured.
Measured: 6 months
Clinical Response of Each Participant measuring Left Ventricular End Systolic Volume.
Changes at 6 months (relative to baseline measurement) in Left Ventricular End Systolic Volume in ml on Transthoracic Echocardiogram. This is a recognised clinical tool that reflects the participant's heart failure status by measuring the left ventricular contractility of the heart.
Measured: 6 months
Clinical response of Each Participant measuring New York Heart Association classification.
Changes at 6 months (relative to baseline measurement) in New York Heart Association classification (class I, II, III or IV). This is a recognised clinical tool that reflects the participant's heart failure status. Class I is least severe and reflects no physical symptoms whilst under going normal physical activity through to class IV, most severe, and unable to carry out any physical activity without discomfort and may have symptoms at rest.
Measured: 6 months
Clinical response of Each Participant measuring 6 Minute Walk Test
Changes at 6 months (relative to baseline measurement) in 6 minute walk test measured in metres. This is a recognised clinical tool that reflects the Participant's heart failure status by measuring how far the participant can walk during a 6 minute period on flat terrain.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Jul 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- EBR Systems, Inc.
- Responsible party
- Sponsor
- Investigators
- Paul R Roberts, MD, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451797
- Sponsor's protocol ID
- DEV DVD0024
- Acronym
- TLC
- Status last verified
- Dec 2023
- First submitted
- 12 Jun 2022
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Into the Implant of the WiSE CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
- ClinicalTrials.gov ID
- NCT05451797
- Acronym / sponsor ID
- TLC / DEV DVD0024
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- EBR Systems, Inc.
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Jul 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.
This study is a single arm, prospective, feasibility, multi-centre, observational study. Participants will be suitable for a Cardiac Resynchronisation Therapy (CRT) implant using Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy, known as the WiSE-CRT device system as well as requiring a pacemaker implant which will also be leadless. Some of these participants may also require an AV Node ablation.
The purpose of this study is to assess the safety and efficacy of these two cardiac devices implanted in the order of operator preference (all implants undertaken on the same day or in a number of up to 4 separate sequenced implants/procedures).
Detailed description
Heart Failure is a serious condition in which the heart is unable to pump enough blood to meet the body's demands. Some heart failure occurs when the heart chambers pump in a desynchronised manner, reducing the amount of blood pumped with each heartbeat.
The National Institute for Health and Care Excellence (NICE) recommends Cardiac Resynchronisation Therapy (CRT) for a subset of these patients. Patients undergoing CRT receive a special implantable pacemaker with an additional lead via the coronary sinus (CS) to synchronise the pumping of the heart chambers (ventricles). CRT works by pacing both the left \& right ventricles to ensure they pump at the same time. This in turn, reduces heart failure symptoms.
CRT is an effective treatment for many patients, but limitations prevent some patients from benefiting:
- 5-10% of patients are considered untreated due to acute/chronic issues with the CS lead
- 30% of patients do not respond/improve
The WiSE-CRT System is an implantable pacing system capable of delivering pacing energy to the heart without using a pacing lead. It was designed to address the persistent limitations of current CRT systems. The WiSE-CRT System operates alongside a co-implanted pacemaker or CRT system and replaces the pacing function of the CS lead.
Intracardiac pacemakers are miniaturized, self-contained, pacing systems implanted directly inside the right ventricle of the heart, eliminating the need for a device pocket and pacing lead inserted into a vein.
By co-implanting both the European conformity certificated (CE marked) WiSE-CRT system and a leadless intracardiac pacemaker, this pilot study will assess the safety and efficacy of implanting a totally leadless system, thereby avoiding both acute and chronic complications associated with the implant of transvenous pacing leads.
This study is a single arm, prospective, multi-centre, observational study. Participants will have initial pre-implant screening baseline measurements prior to implantation of the first system, then will be followed up immediately post implant, then at 1 month \& 6 months post implant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients appropriate for these devices
Key inclusion criteria (9 listed)
- Male or Female, aged 18 years or above. Participant is willing and able to give informed consent for participation in the study.
- Additionally, participants will be enrolled and classified from one of two distinct groups:
- GROUP A: De novo totally leadless CRT
- implant in whom the physician believes a totally leadless approach would be beneficial (e.g. wish to avoid lifelong transvenous lead implant, anatomical constraints, history of device infection). Examples of this could include:
- symptomatic atrial fibrillation (AF) and an uncontrolled heart rate who are candidates for AV node ablation (irrespective of QRS duration and ejection fraction), in whom the physician believes a leadless pacing approach would be beneficial.
Key exclusion criteria (7 listed)
- Female participant who is pregnant, lactating or planning pregnancy during the course of the study
- Inability to comply with the study follow-up or other study requirements
- History of chronic alcohol/drug abuse and currently using alcohol/drugs
- Non-ambulatory (or unstable) NYHA class 4
- Life expectancy less than 12 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 |
|---|---|---|
| Implant of WiSE-CRT with intracardiac pacemakerImplant of two cardiac devices | Device | – |
Primary outcome
Safety from major complications post device implants & procedures
Time frame: 6 months
Freedom from major complications following device implants and procedures, whether single stage or multiple staged procedures. Major complications are defined as any complication related to the device or procedure that results in death, hospitalization, prolongation of hospitalisation for 48 or more hours, permanent loss of device function due to a mechanical or electrical malfunction or system change (removal, repositioning, or replacement).
Efficacy of Cardiac Resynchronisation Therapy (CRT) measured by confirmation of Bi Ventricular Pacing on 12 lead ECG.
Time frame: 6 months
Evidence of biventricular pacing on 12 lead ECG recorded at 6 months will confirm CRT delivered by implanted devices for each participant.
4 secondary outcomes
Clinical Response of Each Participant measuring Left Ventricular Ejection Fraction.
Time frame: 6 months
Clinical Response of Each Participant measuring Left Ventricular End Systolic Volume.
Time frame: 6 months
Clinical response of Each Participant measuring New York Heart Association classification.
Time frame: 6 months
Clinical response of Each Participant measuring 6 Minute Walk Test
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- 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.
Paul R Roberts, MD principal investigator
University Hospital Southampton NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by University Hospital Southampton 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 9 inclusion and 7 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 26 Dec 2023. 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?
Contact elizabeth greenwood, MSc (023 8120 8646, elizabeth.greenwood@uhs.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety from major complications post device implants & procedures (time frame: 6 months). The study lists 2 primary outcomes in all. 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 26 Dec 2023.