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Implant of the WiSE CRT System With an Intracardiac Pacemaker

NCT05451797 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2023-12-26

No results posted yet for this study

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

Interventions

DEVICE

Implant of WiSE-CRT with intracardiac pacemaker

Implant of two cardiac devices

Sponsors & Collaborators

  • EBR Systems, Inc.

    collaborator INDUSTRY

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Paul R Roberts, MD · University Hospital Southampton NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05451797 on ClinicalTrials.gov