Bradycardia Clinical Trial
Official title:
Comparative Follow-up Schedule With Home Monitoring
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03922386 -
Safety and Electrical Performances of XFINE Leads
|
N/A | |
Completed |
NCT03294018 -
Heart Rate Changes Following the Administration of Sugammadex
|
||
Not yet recruiting |
NCT05649891 -
Checklists Resuscitation Emergency Department
|
N/A | |
Not yet recruiting |
NCT05440071 -
PoSt-market Assessment on Safety and Performance of J-sHAPed xFINE Lead
|
||
Completed |
NCT02153242 -
The Effects of Selective Site Right Ventricular Pacing
|
||
Recruiting |
NCT01825473 -
Study of Erythromycin in GER-Associated Apnea of the Newborn
|
N/A | |
Completed |
NCT00950287 -
Detection of Neonatal Bradycardia
|
N/A | |
Completed |
NCT00721136 -
Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation
|
N/A | |
Completed |
NCT00286858 -
Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing
|
||
Completed |
NCT00158925 -
The EASYTRAK EPI Clinical Investigation
|
Phase 3 | |
Completed |
NCT00180557 -
Austria Study - Analysis of Difference Between Active and Passive Fixation Leads
|
Phase 4 | |
Completed |
NCT01076348 -
Model 4965 Post-Approval Study
|
||
Completed |
NCT04198220 -
BIO|STREAM.ICM Obesity
|
||
Recruiting |
NCT05298748 -
The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants
|
N/A | |
Recruiting |
NCT04353960 -
The Alaska Oculocardiac Reflex Study
|
||
Terminated |
NCT04093414 -
Left Bundle Area Versus Selective His Bundle Pacing
|
N/A | |
Completed |
NCT03786640 -
Abbott Brady 3T MRI PMCF
|
||
Recruiting |
NCT05935007 -
Aveir DR Real-World Evidence Post-Approval Study
|
||
Recruiting |
NCT05932602 -
AVEIR DR Coverage With Evidence Development (CED) Study
|
||
Recruiting |
NCT04075084 -
Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
|