Heart Failure Clinical Trial
— TLCOfficial 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).
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 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. - 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. Exclusion Criteria: - 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) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University Hospital Southampton NHS Foundation Trust | EBR Systems, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Analysis of single stage and multiple stage device implant procedure times | Comparing mean procedural times of single stage device implants, or up to 4 stage implant procedure times, as per operator preference. | 6 months | |
Primary | 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). | 6 months | |
Primary | 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. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 6 months |
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