NCT04565652

Brief Summary

Trial to assess the ability of a wearable to detect defibrillation from an implantable ICD

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

March 3, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

September 10, 2020

Last Update Submit

March 22, 2021

Conditions

Cardiac ArrestHeart ArrestCardiopulmonary Arrest

Keywords

ICDDefibrillator

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of investigational device at detecting ICD shocks

    The number of successful detection of ICD shocks using the novel ICD Smartband versus missed events

    1 year

Study Arms (1)

ICD Defibrillation

EXPERIMENTAL

Detection of ICD shock during elective ICD implant using the investigational device

Device: Device Wearers

Interventions

Device WearersDEVICE

The intervention arm will wear the LOIS ICD Smartband during routine ICD defibrillation following elective ICD implant.

ICD Defibrillation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Capable of understanding procedure and making informed consent
  • Listed for elective ICD Implant
  • Having routine DFT as part of elective ICD implantation

You may not qualify if:

  • Not indicated for ICD implant
  • Incapable of making informed consent
  • Pregnant
  • Not on stabilised anti-coagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Dimitrious Panagopoulos, PhD

CONTACT

020 3313 1000d.panagopoulos@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Each patient will knowingly wear the ICD Smartband
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: A single group of patients will wear the LOIS ICD smartband during elective ICD defibrillation
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2020

First Posted

September 25, 2020

Study Start

March 3, 2021

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

March 23, 2021

Record last verified: 2021-03

Locations

GB(1)