Status:
COMPLETED
4P Study: Predictive Quality With Painfree Therapies
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
Medtronic
Conditions:
Cardiac Arrhythmias
Eligibility:
All Genders
18+ years
Brief Summary
The aim of the study is to characterize and quantify the relative effectiveness and contribution of implantable cardioverter defibrillator (ICD) therapy to the clinical outcomes under the conditions o...
Detailed Description
The main role of ICD's is to stop potentially lethal ventricular tachyarrhythmias through overdrive pacing or shock, reducing the risk of sudden cardiac death. The device is programmed to detect episo...
Eligibility Criteria
Inclusion
- Patients having an indication for a Protecta ICD or CRT-D device, or later market released ICD (first implant, replacement, or upgrade)
- Patients monitored with the Carelink monitoring system
- Patients having signed the patient informed consent form
- Patients older than 18 years
Exclusion
- Patients younger than 18 years of age
- Patients with a life expectancy of less than 24 months
- Females, pregnant and of child bearing potential
- Patients participation to another concomitant trial
- Patients unable or not willing to provide a signed patient informed consent
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01509378
Start Date
November 1 2011
End Date
May 1 2016
Last Update
July 3 2025
Active Locations (10)
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1
University Hospital - Basel
Basel, Canton of Basel-City, Switzerland, 4031
2
HFR - Hôpital Cantonal - Fribourg
Fribourg, Canton of Fribourg, Switzerland, 1708
3
HUG - University Hospital Geneva
Geneva, Canton of Geneva, Switzerland, 1211
4
Kantonsspital St.Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007