SmartCardia Wireless Recorder as a Telemetry System

NCT04609436 | Completed DMC

• 1 other identifier: CER 2020-0141
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Patients hospitalized at the clinic Cecil who need telemetry will be monitored for 48 hours with the SmartCardia system in addition to conventional monitoring.

Conditions

Arrhythmias, Cardiac; Monitoring

Keywords

non invasive monitoring

Outcome Measures

Primary Outcomes (1)

• Arrhythmia counting after heart surgery

  The primary outcome is to detect supra-ventricular and ventricular arrhythmias following cardiac surgery. The following data will be reported: 1. Number per minute of ventricular and/or supra-ventricular extrasystoles, 2. Number per minute of supra-ventricular and/or ventricular doublets, 3. Number per minute of supra-ventricular and/or ventricular triplets, 4. Number of episodes/24 hours of supra-ventricular and/ot of ventricular tachycardia (VT) will be measured, 5. Number of episodes of atrial fibrillation will be measured. 6. Number of pause exceeding 2 seconds will be reported.

  48 hours following cardiac surgery part of 10 days of hospitalization post surgery.

Secondary Outcomes (4)

• Duration of arrhythmias after heart surgery

  48 hours following cardiac surgery part of 10 days of hospitalization post surgery.

• Noise analysis

  48 hours following cardiac surgery part of 10 days of hospitalization post surgery.

• Incidence of noise

  48 hours following cardiac surgery part of 10 days of hospitalization post surgery.

• Percentage of episodes of noise.

  48 hours following cardiac surgery part of 10 days of hospitalization post surgery.

Other Outcomes (3)

• Skin tolerance evaluation

  48 hours following cardiac surgery part of 10 days of hospitalization post surgery.

• Skin tolerance assessment (additional measures)

  48 hours following cardiac surgery part of 10 days of hospitalization post surgery.

• Skin tolerance assessment (additional measures)

  48 hours following cardiac surgery part of 10 days of hospitalization post surgery.

Study Arms (1)

Single arm

This is a single arm trial. The patient is his own control.

Device: Cardiac monitoring with the wireless device "SmartCardia"

Interventions

Cardiac monitoring with the wireless device "SmartCardia" DEVICE

Monitoring of arrhythmia with a wireless device (SmartCardia)

Single arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients requiring cardiac monitoring after heart surgery will be included

You may qualify if:

• Any patient who needs to be monitored for at least 48 hours can be included in the study.

You may not qualify if:

• allergic to sticking plaster
• refusing to participate will be excluded from the study.
• planed MRI examination
• open wound
• Severe thorax deformity making recording not possible.

Sponsors & Collaborators

• University Hospital Freiburg: lead

Study Sites (1)

Clinique Cecil

Lausanne, 1003, Switzerland

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Jacques Goy, MD

  Hirslanden Cecil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 30, 2020
• Study Start: February 1, 2020
• Primary Completion: March 1, 2020
• Study Completion: February 1, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)