Implant of the WiSE CRT System With an Intracardiac Pacemaker

NCT05451797 | Unknown FDA Device

• 1 other identifier: DEV DVD0024
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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 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).

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Clinical Response of Each Participant measuring Left Ventricular Ejection Fraction.

  6 months

• Clinical Response of Each Participant measuring Left Ventricular End Systolic Volume.

  6 months

• Clinical response of Each Participant measuring New York Heart Association classification.

  6 months

• Clinical response of Each Participant measuring 6 Minute Walk Test

  6 months

Other Outcomes (1)

• Analysis of single stage and multiple stage device implant procedure times

  6 months

Interventions

Implant of WiSE-CRT with intracardiac pacemaker DEVICE

Implant of two cardiac devices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients appropriate for these devices

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• EBR Systems, Inc.: collaborator

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Paul R Roberts, MD

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

elizabeth greenwood, MSc

CONTACT

023 8120 8646; elizabeth.greenwood@uhs.nhs.uk

elizabeth greenwood, MSc

CONTACT

023 8120 8646; TLCStudy@uhs.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2022
• First Posted: July 11, 2022
• Study Start: July 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share