Status:
COMPLETED
Evaluate the Benefits of Pacemaker Follow-Up With Home-Monitoring
Lead Sponsor:
Biotronik France
Collaborating Sponsors:
Biotronik SE & Co. KG
Conditions:
Pacemaker, Artificial
Bradycardia
Eligibility:
All Genders
18+ years
Phase:
NA
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).
Detailed Description
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 patie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
543 Patients enrolled
Trial Details
Trial ID
NCT00989326
Start Date
December 1 2005
End Date
October 1 2009
Last Update
June 24 2010
Active Locations (1)
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1
CHU Pontchaillou de Rennes
Rennes, France, 35033