Observational Study of Patient Comprehension, Perception, Fears and Appreciation Following Home-Monitoring Implementation

NCT01006746 | Completed

• 1 other identifier: HS050
• Study Type: observational
• Target: 571
• Locations: 1 country
• Sites: 1

Brief Summary

Describe the mutual influences between trainings realized in implantation centers, medico-technical knowledges, technical implementation, perception, fears and appreciation felt by the patients during Home Monitoring implementation.

Conditions

Defibrillators; Tachycardia

Keywords

Remote monitoring; Defibrillators; Survey; Indication for ICD (primary and secondary prevention)

Outcome Measures

Primary Outcomes (1)

• At 1 month: evaluation of centers training, knowledges and constraints of Home Monitoring implementation. At 6 months follow-up: observe and describe the behavior, the perception, the fears and the appreciation degree linked to this new technology

  6 months

Study Arms (1)

ICD patient and Home Monitoring

Patients primo implanted with ICD

Other: Remote monitoring by Home Monitoring system

Interventions

Remote monitoring by Home Monitoring system OTHER

Standard of care completed with remote monitoring for ICD patients follow-up

Also known as: ICD: Lumax family (single-chamber, dual-chamber and CRT ICDs), Transmitter: cardioMessenger II or CardioMessenger IIs

ICD patient and Home Monitoring

Eligibility Criteria

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

Study Population

Patients in 46 french investigational sites (hospitals and private clinics)

You may qualify if:

• Primo ICD implantation with Home-Monitoring system

You may not qualify if:

• NYHA Class IV
• Pregnant women or women who plan to become pregnant during the trial
• Patient whose medical situation is not stable
• Presence of psychiatric illness, depression, anxiety disorders
• Presence of any disease, other than patient's cardiac disease, associated with reduced likelihood of survival for the duration of the trial, e.g. cancer, uraemia (urea \> 70mg/dl or creatinine \>3mg/dl, liver failure, etc.
• Age \< 18 years
• Patient unable to handle the CardioMessenger correctly
• The patient is not willing and able to comply with the protocol (i.e. unable to answer to the questionnaires)
• Change of residence expected during the study
• Participation in another clinical study
• Patient unwilling to sign patient informed consent

Sponsors & Collaborators

• Biotronik France: lead
• Biotronik SE & Co. KG: collaborator

Study Sites (1)

CHU Le Bocage, Dijon

Dijon, 21079, France

Location

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gabriel Laurent, Dr

  CHU Dijon

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 1, 2009
• First Posted: November 3, 2009
• Study Start: February 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 4, 2014

Record last verified: 2014-03

Locations

FR (1)