NCT00989326

Brief Summary

The study investigates whether home monitoring follow-up of Pace-Maker patients is as efficient as conventional method in terms of Significant Serious Adverse Event (SSAE).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
543

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2005

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

December 1, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2009

Completed
Last Updated

June 24, 2010

Status Verified

October 1, 2009

Enrollment Period

3.8 years

First QC Date

October 2, 2009

Last Update Submit

June 23, 2010

Conditions

Pacemaker, ArtificialBradycardia

Keywords

Remote monitoringPacemakerFollow upFollow-up studies

Outcome Measures

Primary Outcomes (1)

  • Number of patients with serious adverse events detected during and at the end of an 18 months follow-up period is compared for the two groups

    18 months

Secondary Outcomes (3)

  • Efficacy of Home Monitoring to detect pacemaker dysfunction

    18 months

  • Reduction of associated cost

    18 months

  • Delay of Home Monitoring to manage adverse events

    18 months

Study Arms (2)

CONTROL group

ACTIVE COMPARATOR

The patients receive standard of care for 18 months. The CONTROL group patients will be equipped with Home Monitoring. However, the Home Monitoring data will not be used for patient surveillance; i. e. the patient will be followed in the conventional manner.

Other: Home Monitoring

ACTIVE group

EXPERIMENTAL

The patients are followed by Home monitoring only. Every patient must be seen by his physician 18 months after enrolment for regular follow-up. Within this period, the additional Pace Maker follow-up or therapeutic intervention will be primarily triggered on cardio-reports reception or patient/physician call

Other: Home Monitoring

Interventions

Home MonitoringOTHER

Both patient groups are followed for 18 months and will be followed with Home Monitoring switched on. The data from the CONTROL group will not be presented online to the attending physician, but a retrospective analysis on differences between the two groups will be performed.

Also known as: Remote monitoring
ACTIVE groupCONTROL group

Eligibility Criteria

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

You may qualify if:

  • The patient is willing and able to comply with the protocol
  • The patient has provided written informed consent
  • Patient whose medical situation is stable
  • Patient with PHILOS II DR-T Pacemaker \>= one month with A/V bipolar lead
  • No change of residence expected during study

You may not qualify if:

  • Spontaneous Ventricular Rhythm \< 30 ppm
  • Heart failure no controlled by medical treatment
  • Post cardiac surgery (\< 1 month)
  • Post myocardial infarction (\< 1 month)
  • More than two cardioversion shocks for last 6 month
  • A/V Lead dislodgement, or/and impedance, threshold, or sensing failure
  • Pocket hematoma with needed intervention
  • Pneumothorax / Hemothorax
  • Infection
  • Automatic Ventricular Threshold Test cannot be realised
  • Patient unable to handle Home Monitoring system correctly
  • Insufficient GSM coverage at patient's home
  • Participation in another clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Pontchaillou de Rennes

Rennes, 35033, France

Location

Related Publications (1)

  • Mabo P, Victor F, Bazin P, Ahres S, Babuty D, Da Costa A, Binet D, Daubert JC; COMPAS Trial Investigators. A randomized trial of long-term remote monitoring of pacemaker recipients (the COMPAS trial). Eur Heart J. 2012 May;33(9):1105-11. doi: 10.1093/eurheartj/ehr419. Epub 2011 Nov 29.

    PMID: 22127418DERIVED

MeSH Terms

Conditions

Bradycardia

Interventions

Blood Glucose Self-MonitoringRemote Patient Monitoring

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicSelf-TestingSelf CareTherapeuticsInvestigative TechniquesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Philippe P MABO, Pr, Dr

    CHU Pontchaillou de Rennes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 2, 2009

First Posted

October 5, 2009

Study Start

December 1, 2005

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

June 24, 2010

Record last verified: 2009-10

Locations

FR(1)