NCT04198220

Brief Summary

The aim of the submodule study is to assess whether a high BMI may influence the sensing performance and the sECG quality of the BIOMONITOR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 12, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

September 17, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

October 22, 2021

Status Verified

December 1, 2020

Enrollment Period

8 months

First QC Date

December 12, 2019

Last Update Submit

October 21, 2021

Conditions

Tachycardia AtrialAtrial FibrillationSyncopeBradycardiaCryptogenic Stroke

Keywords

ObesityBIOMONITORBIOMONITOR IIISyncopeCryptogenic strokeAtrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • R-wave amplitude

    R-wave amplitude at 3-month Home Monitoring observation in patients with a BMI \> 30

    3 month

Secondary Outcomes (2)

  • Amount of 'noise burden'

    3 month

  • P-wave visibility

    1 month and 3 month

Other Outcomes (1)

  • Incidence of arrhythmias

    3 month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patient population consists of obese patients (BMI \> 30 kg/m2) with an implantable cardiac monitor

You may qualify if:

  • Patient is already enrolled in the BIO\|STREAM.ICM registry
  • Patient BMI \> 30

You may not qualify if:

  • Patient clinically indicated for or already implanted with another cardiac active device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Civile Ferrari

Castrovillari, 87012, Italy

Location

Related Publications (1)

  • Bisignani G, De Bonis S, Pierre B, Lau DH, Hofer D, Sanfins VM, Hain A, Cabanas P, Martens E, Berruezo A, Eschalier R, Milliez P, Lusebrink U, Mansourati J, Papaioannou G, Giacopelli D, Gargaro A, Ploux S. Insertable cardiac monitor with a long sensing vector: Impact of obesity on sensing quality and safety. Front Cardiovasc Med. 2023 Mar 21;10:1148052. doi: 10.3389/fcvm.2023.1148052. eCollection 2023.

    PMID: 37025684DERIVED

MeSH Terms

Conditions

Atrial FibrillationSyncopeBradycardiaIschemic StrokeObesity

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsStrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • Giovanni Bisignani, Dr.

    Ospedale Civile Ferrari

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2019

First Posted

December 13, 2019

Study Start

September 17, 2020

Primary Completion

May 26, 2021

Study Completion

September 1, 2021

Last Updated

October 22, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)