Evaluate the Benefits of Pacemaker Follow-Up With Home-Monitoring

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

543 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function

NCT00538356

Ventricular Fibrillation Ventricular Tachycardia Congestive Heart Failure

COMPLETED PHASE4

Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications

NCT00976482

Bradyarrhythmia

COMPLETED

Benefits of Implantable Cardioverter Defibrillator Follow-up Using Remote Monitoring

NCT00989417

Implantable Cardioverter-Defibrillators Ventricular Fibrillation Tachycardia, Ventricular

COMPLETED NA

LIFE Study - Limiting Chronotropic Incompetence for Pacemaker Recipients

NCT00146861

Bradycardia

COMPLETED PHASE4

PREFER (Pacemaker Remote Follow-Up Evaluation and Review)

NCT00294645

Bradycardia Arrhythmia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Due to its integrated long-distance telemetry, the implantable pacemaker Philos II DR-T is capable of periodically transmitting data from the pacemaker memory to the BIOTRONIK Service Center via patient device. The BIOTRONIK Service Center decodes the data and presents it to the physician on a password secured internet site. Additionally, in case certain event criteria are met, the most important Home Monitoring information are immediately faxed to the physician as an Event Report. These events can be customised by the physician. Thus, the physician will be able to closely monitor the patient and check the adequacy and efficiency of the pacemaker therapy without requiring the patient to visit the physician. The transmitted data comprise information on atrial and ventricular rhythm, atrioventricular conduction and system status.

The purpose of the national prospective, randomized, multicentric clinical study "COMPArative follow-up Schedule with home monitoring" (COMPAS) described here is to evaluate the benefits of pacemaker follow-up with home monitoring in France. The standard follow-up or therapeutic intervention will be deemed based on faxed event Reports reception and Cardio reports analysis on internet site. During the clinical study, the incidence of serious adverse events (hospitalisation, pacemaker dysfunction, and cardiovascular events), economic impact, safety, and practicability will be analysed. The findings from the ACTIVE group will be compared to those of a group receiving standard of care (CONTROL group). 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.

The trial will be conducted as a prospective, randomised, open, multicenter, national clinical trial. The enrollment of 400 patients in 50 clinical centres in France is anticipated. The principal inclusion criterion is indication for dual chamber pacemaker/ICD implantation. Main exclusion criteria comprise pacemaker dependency.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pacemaker, Artificial Bradycardia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CONTROL group

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.

Group Type ACTIVE_COMPARATOR

Home Monitoring

Intervention Type OTHER

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.

ACTIVE group

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

Group Type EXPERIMENTAL

Home Monitoring

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Home Monitoring

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Remote monitoring

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes