4P Study: Predictive Quality With Painfree Therapies (4P)
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|ClinicalTrials.gov Identifier: NCT01509378|
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : June 9, 2016
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 of daily practice.
Swiss, multicenter, prospective, observational study.
|Condition or disease|
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 episodes of arrhythmias, classify them according to the threat to patient, and deliver therapies to stop the arrhythmias.
The actual focus of ICD programming has been the application of fast-pacing therapies (ATP or antitachy pacing) as first therapy before applying a shock as last resort to terminate an episode. Some studies have shown the high success rate of this method in decreasing the number of shock delivered to patients. Furthermore significant improvement has been done to improve the sensitivity and specificity of the detection and discrimination algorithm.
This study will focus on the latest generation of device and their performance will be reviewed and analyzed by an Adjudication Board.
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||4P Study: A Prospective Study on Predictive Quality Preferring PainFree Therapies|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
- Number of successful and non successful therapies [ Time Frame: 24 months follow up ]First assessment and analysis of therapy efficacy and appropriate detection and classification
- Number of device diagnostics alerts and device integrity alerts [ Time Frame: 24 months follow up ]First assessment of alerts and classification
- All causes hospitalizations, cardiovascular hospitalizations, death, severe adverse events (SAE) [ Time Frame: 24 months follow up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509378
|University Hospital - Basel|
|Basel, BS, Switzerland, 4031|
|HFR - Hôpital Cantonal - Fribourg|
|Fribourg, FR, Switzerland, 1708|
|HUG - University Hospital Geneva|
|Geneva, GE, Switzerland, 1211|
|St.Gallen, SG, Switzerland, 9007|
|CardioCentro Ticino - Lugano|
|Lugano, TI, Switzerland, 6900|
|CHUV, Centre Hospitalier Universitaire Vaudois|
|Lausanne, VD, Switzerland, 1011|
|GZO Spital - Wetzikon|
|Wetzikon, ZH, Switzerland, 8620|
|Klinik Im Park - Zurich|
|Zurich, ZH, Switzerland, 8038|
|Stadtspital TRIEMLI - Zurich|
|Zurich, ZH, Switzerland, 8063|
|USZ - University Hospital Zurich|
|Zurich, ZH, Switzerland, 8091|
|Principal Investigator:||Martin Fromer, Professor||CHUV, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland|
|Study Director:||Mayella Favre||Medtronic (Suisse) SA|